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From Jack Quinn Solutions, L. L.C

CPSM Certification Coaching Online Course - ...etech a First, the Boot Camp provided a thirty day plan to successfully pass the CPSM testing. The first weeks including preparation for the sample tests, a method to do further focused studying, more review, more testing. A very complete, structured format was provided, along with a lot of resource materials.a a I did a lot of research prior to enlisting in the Boot Camp and I more...

From Tools 2 Succeed, Inc

Time Management Webinar

Do you know the difference between the urgent and the important? Do you make time for the important? Most people go through life by default; learn to live your life by design! In our interactive Time Management webinar, you will learn: * How you are currently using your time * The barriers which keep you from managing your time more effectively * The difference between important and more...

From Requirements Solutions Group

How to Plan Prepare and Manage Acceptance Testing

...plan is similar to taking off without a flight plan. If you dona ™t know what needs to be done to responsibly validate that an information technology solution meets the defined business, stakeholder, solution, and transition requirements, you place the project (and potentially your organization) at risk. This online business analyst testing course teaches you how to select a testing more...

How to Plan Business Analysis Activities and Manage Risks

...Planning business analysis activities is often perceived as a project manager responsibility. Indeed, what makes the business analysis activities of a project any different than any other activity? Because study after study indicate that missed or misunderstood requirements are the number one cause of project failure, paying special attention to these critical areas would seem to be a good more...

How to Track and Monitor Business Analysis Activities

...planned and scheduled, tracking the activities and monitoring progress on the project can consume a lot of the time allocated for business analysis. If not done properly, these activities can cause you to spend more time working in a project manager capacity and neglecting the requirements gathering activities that are the prime responsibility of the business analyst role. This 7-hour more...

How to Manage Changing Requirements

Managing requirements change has been a major challenge even for the best-run projects. Keeping track of how the changing business environment impacts ongoing projects and production applications can be a nightmare without proper tools and techniques. The concept of requirements management is not new but with an increase in the use of off-shore developers and off-the-shelf solutions, it has become more...

From TDM Webacademy

E104-7 Operations Management

Description: The architect of a business is its operations management. That is how and what are the tasks of decision making, planning and control, and efficiently scheduling material and labor - all of which is critical issues to successful growth of an organization. This webinar provides an examination of how to identify and address operational issues that face the organization and more...

E104-8 Human Resource Management

Description: The human resources of a business are the employees of the business. Good employees provide the path for a business to survive and thrive. As such it is important to implement strategies to maximize on employee skills and performance. This webinar provides an examination of the strategies needed to have a well-thought-out hiring plan in place that supports the overall business more...

E103-5 Organizational Structure and Management Plan

The foundation of the success of a business is the quality of the people that works there. For this reason, particular attention must be paid to your organization structure and the key players that manage the day to day operations. This webinar provides an analysis of a business organizational structure, including principle or key employees and identifies strategies needed to develop a more...

E103-4 Marketing and Sales Strategies

...plan is critical for businesses to compete and achieve success. This webinar is the fourth in the series designed to provide an analysis of effective marketing and sales strategy concepts. The objectives of this webinar are to provide participants with the knowledge and skills. This webinar is the fourth in the series designed to provide an analysis of effective marketing and sales more...

E103-6 Operations Planning

...planning is forgotten or not given the proper consideration when starting a small business. The fact of the matter is that, understanding how to how to manage the day-to-day functions of the business increases the potential for success when starting a business. This webinar provides an analysis of a business operations strategy to manage a business which includes the day-to-day inputs, more...

E103-7 Financial Planning

The core of any business is a sound financial planning. Therefore, it is essential to have an understanding of business financials in order to start a business. This webinar provides an analysis of a business financial plan for managing and operating a business. Specific focus is on income analysis, cash flow analysis, business assets, business liabilities and financial assumptions. more...

E103-8 Exit Strategy Plan

A key component in developing a business plan is to determine an exit plan. That is, planning how to exit or end your business is just as important as planning to start your business. This webinar provides an analysis of how to develop long-term plans as to how and when a business shall close or transfer ownership. more...

E104-1 Development and Growth Strategies

Starting or creating a business lays the foundation for success. To be a successful entrepreneur, one must continuously explore strategies that build on the foundation. This webinar provides an examination of strategies needed to develop and grow a business and to meet business goals and objectives more...

E103-3 Competition

It is important for businesses to know what other businesses are doing so that they can match or improve their product or service. More importantly, businesses should know what the consumer preferences are in order to maintain an advantage over other businesses that sell the same or similar products. This webinar provides an analysis of a business competitive position and market share more...

E103-9 Wrap-up Cover Page Statement of Purpose Table of Contents and Executive Summary

...plan is to ensure that the reader such as potential lenders and/ or investors can instantly seek critical information that will spark their interest; has a summary of the main points of the business plan and a statement that spells out the purpose of the business plan. This webinar provides an analysis of creating a cover page, preparing a statement of purpose and r summarizing the business more...

E103-1 Business Concept and Description

What Business should I start? This is the question asked by most individuals who are thinking about starting a business. The answer to those question is defined by coming up with an idea and turning it into a business concept. This webinar provides a detailed analysis of defining a business concept and providing a business description section of the business plan. more...

E101 Entrepreneurial Spirit Within

Description: Many successful entrepreneurs have stated that the desire to own a business has always been a dream. So a very young age they started to small ventures such as lemonade stands, cutting lawn and, shoveling snow. At a very young age these individuals was cultivating the knowledge and skills necessary to become a successful entrepreneur. Objectives: This webinar explores those more...

E103-2 Target Market and Industry Analysis

Description: The success of starting and managing a business depends heavily on the understanding that an entrepreneur has created an environment in which customers, businesses, and certain economic conditions interact. That is, understanding the customers (target market) and the environment (industry). This Webinar provides an analysis of a business target market and industry. more...

E102 Starting a Small Business The Formula for Success

Description: The formula to grow a business from start-up to success requires more than just skills, business knowledge or experience. The formula for success is a culmination of knowledge and skills matched with prospective opportunities. This webinar examines the steps in starting a business by fully exploring the concepts of identifying opportunities and then matching skills and knowledge more...

E104-2 Business Certifications

Obtaining business certifications can be very beneficial. Such certifications can provide opportunities such as in local, state and federal government contracts. This webinar provides an examination of the requirements and benefits of government certification at the federal, state and local levels. Objectives: The objectives of this webinar are to provide participants with the knowledge and more...

E104-5 Fiscal Management and Soundness

...s webinar provides an examination of how to determine and plan for an organizational fiscal management and soundness position. Objectives: The objectives of this webinar are to provide participants with the knowledge and skills to: Define what fiscal management and soundness means to your organization. Identify and define fiscal responsibility and accountability within your organization. more...

E104-4 Procurement Opportunities

Procurement is when a business purchase of goods and/ or services at the best possible total cost. The process of procuring or purchasing such products and services requires a organized process by both the organizing that are procuring products or services and the business that are providing such products or services. This webinar provides an examination of a basic procurement process, more...

E104-3 Marketing Strategies

Your business marketing strategy can be the factor that determines a business success or failure. That is, the business owner must determine their choice of customers and how they intend to reach those customers. This webinar provides an examination of how to identify, prioritize and implement marketing strategies to help grow a small business either through getting more sales or increasing more...

E104-6 Legal Considerations

Description: One of the steps in ensuring prospects for future business success is to ensure that legal and compliance are addressed. This webinar provides an examination of key legal considerations that impacts an organizationa ™s growth and supports the goals and objectives of the organization. Objectives: The objectives of this webinar are to provide participants with the knowledge and more...

From Black Box Consulting

Xilinx FPGA Academy III - Advanced

...PGA Editor. There are 2 days indepth training on using Plan ahead for Timing closure, area constraints, IP reuse, compression and run time improvement techniques. We spend a further day looking into more advanced uses and features of the Chipscope software. The Xilinx FPGA Academy III contains the following courses: * Advanced FPGA Implementation (2 days) * Advanced Design more...

From Kogent

BOC310 - Crystal Reports - Report Design I - Fundamentals of Report Design - Virtual Session BOC310: Crystal Reports - Report Design I - Fundamentals of Report Design - Virtual Session Crystal Reports 2008 is a powerful, dynamic, actionable reporting solution that helps you design, explore, visualize, and deliver reports via the web or embedded in enterprise applications. This two-day instructor-led course is designed to give you comprehensive skills and in-depth knowledge to plan and more...

From RAMCO Software Training

Online Training We have taken our proven methodology from the live classroom environment to the virtual classroom with our new E-learning curriculum and online delivery style. Live or recorded, online training is now available for open enrollment and private groups with specific training needs. E-learning courses for Microsoft Office include Excel Basics, Charts, PivotTables, and Formulas and Functions. more...

From Last Minute Training

Project 2007 Refining a Project Plan Learn to apply calendars to tasks and modify task relationships. Understand how to work with task constraints and task deadlines. Also learn how to create a resource pool for your project file. more...

From Healthcare and Medical Information Solutions

Health Information Technology Introduction

...HIT) acquisition, use, and operations; or be a person who plan to take HIT Certification courses at their local college and/ or university. Each of the sessions below are three to four hours long. These sessions along with certification from an approved certification center will prepare you for a career in Health Information Technology. HCMI Solutions Internship opportunities are available more...

Health Information Technology Systems

From People Biz Inc.

Hiring Plan Webinar HIRING PLAN | Thursday, November 10, 2011 | 2: 00 PM a 5: 00 PM CST Led by Alicia Marie How do you know when it is time to hire? What role is the right one? Identify a strategy for building your organization as well as a hiring process for identifying talent. Save time, money and the headache of a bad hire. Register Here: more...

Strategic Planning Webinar WEBINAR PRICING: $39 General Admission $29 CMI Awardees Free to Current Coaching Clients of People Biz, Inc. Register Here: STRATEGIC PLANNING| Friday, October 14, 2011 | 1: 00 PM a 4: 00 PM CST Led by Paula Fracasso Create a vision statement, mission statement, and practiced values as the foundation for your business plan and culture. Then get step-by-step instruction on how to more...

From DiscoveryFuel. com

Green Business Planning - Online Workshops

...Plan (An Online Workshop) Join Vic Desotelle from DiscoveryFuel. com for an online business planning series. http://discoveryfuel. com/ green-business-planning-workshops These workshops are for small business entrepreneurs who have dreamed of owning a sustainable business. Learn how to make a viable business plan that moves your green idea from conception to successful execution. more...

From Webucator

Web Design and Usability Techniques For many new or intermediate Web designers, it ' s difficult to know where to start when designing a site. It ' s easy to make the mistake of assuming that the functionality of a site will take shape over time, or the design will fall into place as you build the site. This web usability training class provides guidance in how to plan and design functional, successful web sites. more...

Time Management Training ...ls and set priorities, develop an overall time management plan, discuss the Pareto principle, assign a price to time, conduct a time audit, and correctly identify and control poor time management personality types. Course activities also cover managing their time to increase their productivity, developing a daily plan, managing technology, and saying " no " to doing too much. Students will more...

Introduction to Microsoft Project 2007 Training

Microsoft Office Project 2007 enables you to create and manage your projects in a standalone desktop environment. In this Microsoft Office Project 2007 training class, you will create a project plan containing tasks, organize these tasks in a work breakdown structure containing task relationships, create and assign resources, and finalize the project to implement the project plan. You will also more...

MOC 6445 - Implementing and Administering Windows Small Business Server 2008 This Windows Small Business Server 2008 training class provides students with the necessary knowledge to plan and implement Windows Small Business Server 2008. Students gain first-hand knowledge on topics such as installing, migrating, monitoring, securing, and backing up data. more...

MOC 6294 - Planning and Managing Windows 7 Desktop Deployments and Environments This Windows 7 training class is intended for desktop administrators who want to specialize in desktop deployment, configuration, and management . In this Windows 7 course, students will learn how to plan and deploy Windows 7 desktops in large organizations . They will also learn how to design, configure, and manage the Windows 7 client environment. This Windows 7 course helps students prepare for more...

MOC 4995 - Programming with the Microsoft .NET Framework using Microsoft Visual Studio 2005 This .NET training class enables developers who are migrating from a different development language, an earlier version of Visual Basic .NET or Visual C#, or who have completed entry-level training and experience using Microsoft Visual Studio 2005, to gain in-depth guidance on programming the Microsoft .NET Framework versions 2.0 and 3.0 with Visual Studio 2005.This training class targets more...

MOC 2278 - Planning and Maintaining a Microsoft Windows Server 2003 Network Infrastructure ...vides students with the knowledge and skills necessary to plan and maintain a Windows Server 2003 network infrastructure.This training class is appropriate for individuals employed as or seeking a position as a systems engineer. The class is also appropriate for individuals currently supporting a competitive platform who want to enhance their job skills on Microsoft Windows Server 2003 more...

Marketing Essentials This marketing training is designed for business people with little or no knowledge of marketing practices, as well as inexperienced marketing professionals. Students will develop strategic and tactical skills to create, execute, and evaluate a marketing plan. more...

SharePoint 2007 Governance Training This SharePoint training course covers the ins and outs of governance in general as well as common taxonomies. You will review what a Governance plan is made up of, as well as learn how to create a training plan, SharePoint service offerings and how to follow through with enforcing the plans. We will review Information Architecture and why it is important.We will take a look at each level in more...

Budgeting Training: Budgeting Basics In this budgeting training course, students learn create, review, and manage budgets. Virtually every aspect of budgeting is covered, from preparing income statements and company expense reports, to developing your own personal plan. Students learn about different types of budgets and the elements of a successful budget. Students also learn how to create a budget, analyze and compare budgets, and more...

Business Problem Solving and Strategic Decision Making ...on Strategic Decision Making. Students will learn how to plan, frame, and research decisions. Students also learn how to define decisions, apply appropriate decisions frames, avoid overconfidence, deal with uncertainty, generate options and select the best one, develop numerous high-quality options, evaluate the options and make a final choice, review and learn from experience, identify more...

Strategic Decision Making Training ...c Decision Making training course teaches students how to plan, frame, and research decisions. Students learn how to define decisions, apply appropriate decisions frames, avoid overconfidence, deal with uncertainty, generate options and select the best one, develop numerous high-quality options, evaluate the options and make a final choice, review and learn from experience, identify optimal more...

Managing Performance Training This Managing Performance training course teaches students the basics of creating a performance plan and the appraisal process. Students will learn how to conduct a performance-planning meeting, document the performance plan, provide positive and constructive feedback, coach employees during the appraisal period, appraise employee more...

MOC 6451 - Planning, Deploying and Managing Microsoft System Center Configuration Manager 2007 ... class provides students with the knowledge and skills to plan, deploy, and manage Configuration Manager 2007. The class focuses on planning and deploying sites and clients, configuring software distribution, deploying operating systems, and managing software updates. It also focuses on remote tools and managing mobile devices.This training class is intended for Systems Engineers with one to more...

MOC 5928 - Managing Projects ...vides students with the knowledge and skills to initiate, plan, execute, monitor and control, and close enterprise projects by using the Microsoft Office Project Server 2007 enterprise tool.This is the second class in the Microsoft Office Project 2007 Official Curriculum series and covers the Microsoft Enterprise Project Management (EPM) Solution.This training class is intended for experienced more...

MOC 2279 - Planning, Implementing, and Maintaining a Microsoft Windows Server 2003 Active Directory Infrastructure ...es students with the knowledge and skills to successfully plan, implement, and troubleshoot a Microsoft Windows Server 2003 Active Directory directory service infrastructure. The course focuses on a Windows Server 2003 directory service environment, including forest and domain structure, Domain Name System (DNS), site topology and replication, organizational unit structure and delegation of more...

From Manufacturing Executive Institute

How to Conduct an Effective Monthly Variance Review Meeting ...plant manager and a GREAT plant manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually, though not always, stated in terms of dollars. more...

From GlobalCompliancePanel

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities

...gislative mandate to audit compliance, and a random audit plan under way, you need to be prepared to respond to audit requests. The features that must be available in EHR systems and the questions to ask system vendors will be described. The processes for responding to requests for copies of electronic records and accountings of disclosures will be related to the regulations that require them. more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth ...n attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key performance indicators (KPIs) of success more...

Job Evaluation Methods and Plans - Webinar By TrainHR ...eaker will review the purpose and types of Job Evaluation Plans, used to establish grade levels for a company's job classifications. Job Evaluation Plans such as Ranking, Paired Comparison, Whole Job Method, Hay Plan, Factor Comparison, GS Classification System, Single Factor, Limited Factor, and Competency based plans will be addressed. In addition, the factors leading up the Job Evaluation more...

Telecommuting Effective Policies Practices and Program - Webinar By TrainHR This session will also cover how employees might approach their management with a proposal to adopt either a full telecommuting plan or hybrid and how to measure and justify positive results. This webinar will contain an overview of how to develop a policy more...

Contingency Plan for Disasters - Are You Prepared - Webinar By GlobalCompliancePanel Most medical and dental practices are ill prepared for disasters. In addition to the enormous difficulty in returning to business following a disaster, OSHA and HIPAA rules now require that medical and dental practices have a plan of action that will ensure that patient data will not be lost and to also have a plan in place to provide a return to care for its patients. Tuesday, November 8, 2011 more...

Dispel the Loss Leader Myth Blueprints to Increase Hygiene Department Services and Production - Webinar By mentorhealth You've tried getting new patients to fill the holes in your hygiene schedule....now its time for a new approach! Fill the holes with your existing patients by learning how to treatment plan non-surgical cases. Thursday, October 13, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Risk Management during device design according to ISO14971 - Webinar By GlobalCompliancePanel Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel There is an on-going major shift in the emphasis of U. S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...mpliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy compliance. A CCMP defines to your organization, as well as to auditors, how you mitigate the risks of the specific contaminants for your products. Areas Covered in the Session: What is a CCMP and how is it more...

From ZaranTech.com

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ...on Tips should attend? Following professionals should plan on joining: a Entry-level IT a Non IT professionals aspiring to get into J2EE/ JEE. a Self-taught IT J2EE/ JEE wanting to fill in the gaps and put all the pieces together a Systems Analysts and programmers interested in expanding their role into new Technology. Here are some videos explaining how we conduct our more...

From GlobalCompliancePanel

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements. more...

Master Validation Planning - Webinar By GlobalCompliancePanel A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated. more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ecent Audit "Hot Buttons" The Part 11 Project Validation Plan The Simplified Approach to 21 CFR Part 11 Compliance and Software V&V When and How to Use DQ, IQ, OQ, PQ (or their equivalents) Simplified Sample V&V Test Cases and their Development The FDA's 11 Key V&V Documentation Elements GAMP / Other Considerations Who Will Benefit: Senior management in Drugs, Devices, Biologics, more...

Controlling Workers Comp Injuries As Your Workforce Ages This webinar will focus on gaining a better understanding of the older worker at work so you know what to expect as our workforce ages. Older employees now constitute a larger segment of the workforce than in previous years. In general, for most states up to 20% of workersa ™ in most industries are 55 or older. It is projected by the BLS (Bureau of Labor Statistics) that by 2016, almost more...

Document Retention and Destruction ...ctive Human Resource Departments should have a documented Plan to manage employee records safely and effectively. Why should you attend: In order to be in compliance with recordkeeping compliance you should review your policies and practices on record retention and destruction on a regular basis. This webinar will cover federal record-keeping requirements for confidential and sensitive human more...

Document Retention and Destruction by TrainHR You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish more...

Introduction to Risk Management - Webinar by GlobalCompliancePanel

This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department. more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...s involving multi-million dollar fines and settlements. A plan for attaining compliance will be presented. The steps to follow to prepare for an audit and respond to an audit request will be outlined. Areas Covered in the Session: * Fines and penalties for violations of the HIPAA regulations have been significantly increased and now include mandatory fines for willful negligence that more...

Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ... Recent Audit "Hot Buttons" * The Project Validation Plan * Product and Process / / Facilities / Equipment Software V&V * When and How to Use DQ, IQ, OQ, PQ (or their equivalents) * GAMP / Other Considerations * The FDA's 11 Key V&V Documentation Elements * "White Box" and "Black Box" Validations Who will benefit: * Senior management in Drugs, Devices, more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution. Areas Covered In the Session: * Regulatory "Hot Buttons" * The 4 Basic Steps to Problem Solving * A Suggested Investigation Template * ID / Document the Problem * Investigation / Analysis Methodology - The 7 RCA "Tools" * Find the Solution(s) * Monitor for more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel Overview: This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...on of the inspectors. We will review and illustrate audit plans, system inventory, system audits, CAPA and remediation programs. Why should you attend: "Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel Overview: This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...cation (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel Overview: The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to identify some of the most important points on the curve, including the AQL and RQL more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel Overview: As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems) more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...he PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly. Why should you attend: All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. more...

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From GlobalCompliancePanel

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily. more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...evelopment of an effective equipment qualification master plan * Calibration/ qualification phases: design qualification, installation qualification, operational qualification, performance qualification * Allocating equipment to qualification categories A, B and C * Qualification and documentation requirements for each category * Going through the category example list more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...s and signatures * Use of "NA" * Comments and explanations * Handling raw data (charts, strips, printouts) * Blanks * Entering numerical data Who Will Benefit: * Production personnel (operators, supervisors) * Laboratory personnel (chemists, technicians, supervisors) * Batch record reviewers * QA Auditors of Production and Laboratory Documents more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel Overview: This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel Overview: This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...sment * Reviewing and updating the validation master plan for existing systems * Going through the validation lifecycles from planning to ongoing tests in routine use * Documenting validation results for FDA/ EU compliance * Dealing with requirements for electronic records/ signatures: Part 11, New Annex 11 Who Will Benefit: * IT managers and system administrators more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel Overview: The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included. more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...tion will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...f User Requirements Specifications, the validation master plan, IQ, OQ and PQ expectations, and a comprehensive review of how to utilize USP Chapter 1223, Ph. Eur. Chapter 5. 1.6 and the PDA Technical Report #33. Areas Covered in the Session: * Learn how to develop a validation strategy * User requirements specifications (URS) * Design Qualification (DQ) * Supplier more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...ion of deviations and failures, the failure investigation plan, and effective root cause analysis for corrective actions. Areas Covered in the Session: * Elements of a thorough investigation process (Discovery through Closeout) * Identifying the Problem * Introduction to Root Cause Analysis * Define corrective action and preventive action * Effective Documentation more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...Seminar: * History of design control * Design planning * Design input/ output * Design reviews * Design documentation * Design transfer * In-process design control Who will benefit: This webinar will provide valuable assistance to all companies that perform design activities. The employees who will benefit include: * R&D Personnel and Management more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel Overview: This course provides regulatory/ quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel Overview: Virtually all field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...l device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...put to calculate sample sizes and prepare the statistical plan. * Ensure availability of suitable non-clinical and clinical research data (eg Phase 1, phase II) information to justify carrying out this clinical study * Prepare outline of the protocol * If the study is carried out in EU obtain the EUDRACT number in accordance with the Clinical Trial Directive requirements * more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...lems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel Overview: This three hour overview of investment risk will provide the fundamentals to market, portfolio, and credit risk management that all investors, and those in financial services need to comprehend. Regardless of job titles, investment risk management is a shared responsibility by a wide range of managers. Compared to accounting, risk is an immature discipline with a variety of risk more...

From Guru - Your Online Mentor

Information Security - Overview

Information security means protecting information and information systems/ assets from unauthorized access, use, disclosure, disruption, modification or destruction. Every individual who deals with information should have a better understanding on how to safeguard his/ her personal or company's data. This session will assist partcipants to 1. Understand WHAT, HOW & WHY of information more...

From GlobalCompliancePanel

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...20. 70(i), and explains the requirements for a validation plan. The FDA Guidance document, General Principles of Software Validation, has a section devoted to this kind of software application. The seminar explains FDAa ™s thinking and shows how to follow the guidance document. Lastly, we look at the electronic record aspects of the spreadsheet. 21 CFR 820. 180 provides General more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...is webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards. more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...ngs and common pitfalls as well as tools for a successful planning and execution of the audit * Module 4 - Audit Trails o Types of audit trails o Strategies for implementing complaint audit trails o Pros and cons of audit trails o How to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel Overview: Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on the development of good user requirements. Such requirements can be utilized to determine the extent of validation and to target the testing effort on the critical, regulated functionalities of the PDMA system. The result is a validation effort that can be more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...nagement Responsibility * Resource Management * Planning and Realization of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan a Critical control points * Verification * Corrections and Corrective Actions * Handling of Potentially Unsafe Products * Recalls * more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...cessity for the prescription and the individual treatment plan leading to the prescribing of a narcotic as part of the patient care. * Discuss DEA record-keeping requirements pertaining to: Biennial Inventory; Executed or Voided DEA Form 222 and Invoices; Power of Attorney; Theft and Loss; Drug Destruction; and the Storage of Prescriptions. * Identify DEA security requirements more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...e "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...s in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that can be more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...rview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits. more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...w to go about developing and implementing your compliance plan * Discover how information flow analysis and risk analysis can make sense of your compliance objectives * Find out about the special security challenges of remote access and portable devices * Come away with a six-step plan to organize your security compliance project Agenda: * Information Security more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...el in any operation can be employed in the risk reduction planning and implementation efforts. The session will also provide information regarding how to reduce supplier risk levels. Why you should attend: Management from any food handling company interested in learning a basic thought process that will help them to reduce the risk of being caught in a food recall should consider attending. more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...nderstand how the changes affect your organization * Plan for implementing new requirements * Learn how to attain compliance * Find out about new penalties and enforcement of HIPAA * Discover the Changes to HIPAA Practices in the areas of: o Business Associates o Breach Notification o Accounting of Disclosures o Restriction of more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ... will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...nsequences, and if that device was either a permanently implantable device or a life-sustaining or life-supporting device used outside a device user facility. Section 519(e), as revised by FDAMA, states the agency may require tracking for a class II or class III devices: (A) the failure of which would be reasonably likely to have serious adverse health consequences; or (B) which is intended to more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...he PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. TO not follow the protocol is folly. Why Should You Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel ...red increase their sample size. Most auditing sampling plans are based on either the binomial or normal distribution, though rare events usually follow the Poisson distribution. This talk will show how the Poisson relates to the binomial and normal distributions. Special attention will be given to risk management strategies. A review and comparison of different sampling strategies will be more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...ted Areas for Annual Reviews * The Master Validation Plan -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities; Production and Process Controls * Suppliers, Contract Employees, Consultants * Some basic OSHA Concerns; ties to the cGMPs * Adverse Events Reporting Who Will Benefit: * Senior management in Drugs, Devices, more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical. more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2) more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel Overview: The structure of ISO 9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar. more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel Overview: This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - Webinar by GlobalCompliancePanel This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plana ™s performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to more...

Process Verification and Validation - by GlobalCompliancePanel This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also more...

Root Cause Analysis Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software more...

Computer System Validation Step-by-Step - Webinar by GlobalCompliancePanel Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report. more...

Using Statistics to Determine Sample Size - Webinar by GlobalCompliancePanel This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and more...

Interfacing Design Verification Process Validation and Design Validation - Webinar by GlobalCompliancePanel There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements. more...

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes more...

How to Write Standard Operating Procedures SOPs and Work Instructions WIs - Webinar by GlobalCompliancePanel This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. more...

Project Management for the Phase 3 LCM Life Cycle Management of the Drug Development Process - Webinar by GlobalCompliancePanel This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials. more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes more...

Understanding Analytical Test Results Comparing Two Sets of Data - Webinar by GlobalCompliancePanel The class will cover the understanding the properties of single test results and how they may be compared. There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel This program will focus on the basics needed to perform an API audit. Performing an audit is not simply an act of visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and the tools to utilize during an audit is also discussed. Audits at best are more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...cation (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...e FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, more...

BRC Risk Analysis - Webinar by GlobalCompliancePanel Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical more...

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe. more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan ... failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, more...

Regulatory Complaint Handling MDRs Recalls - Webinar by GlobalCompliancePanel Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar, more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's more...

Using SLAs to Facilitate Enterprise and IT Governance Risk Management and Compliance GRC - Webinar by GlobalCompliancePanel This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them * more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...fy the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...nals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar b Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and more...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel Product traceability requirements for meeting Food Safety and Quality standards as required by BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported more...

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to more...

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