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Requirements Training Seminars and Classes
From Bureau Veritas Training
FREE - FSSC 22000 Food Safety Training - Webinar instructor led trainingon-line e-learning cbt (computer based)group study and discussioncourseware ...Requirements and PAS 220 is the Requirements for Prerequisite Programs. Both standards combined, with 2 extra requirements, equal the FSSC 22000 standard. This Webinar will start at 11: 00 AM (Central USA Standard Time) on Friday, October 28, 2011 and be presented by Patrick Bele, Bureau Veritas Food Safety Program Manager and Senior Lead Auditor. This Webinar is a web-based slide  more...
From Biologix Solutions LLC
Kentucky Mandated HIV-AIDS and Domestic Violence Training on-line e-learning cbt (computer based)study at home Biologix Solutions LLC offers online Kentucky Mandated HIV/ AIDS & Domestic Violence Training for Licensed & Non-licensed Health Professionals. CEs Available : HIV/ AIDS-2CE Hours, Domestic Violence - 3CE Hours. Please Visit website for more information and online sign-up. Our course are accepted by the Kentucky State and meets the requirements of the State of Kentucky's HIV/ AIDS and  more...
From Sql Server Online Training
MSBI SSIS SSAS SSRS Online Training SQL School We are from SQL School, a renowned center for Excellent Online Training and Real Time Projects. We are committed to deliver trusted, quality trainings on MSBI ( SSIS, SSAS & SSRS ) for working SQL Developers and DBAs. All concepts (including clustering) will be discussed practically. NO PPTs or SCREENSHOTS during the live sessions. We will provide the material and FAQs separately. Features of  more...
From Radiofrequency Safety International Corporation
RF Safety Certification Package This course is recommended for all persons with the potential to be exposed to RF Radiation while on a worksite. It is a series of two courses (RF Safety 101 and 201) designed to provide attendees with the understanding of industry standard best practices for working safely around RF. The participant will have the ability to obtain the necessary knowledge to work safely at locations that may  more...
RF Safety 201 This course builds upon lessons learned in RFS 101 and is also an option for recertification. Course Topics Include: More in-depth RF Safety basics and reviews steps to compliance using Best RF Safety Practices, changes regarding MPE rules and compliance requirements mandated by OSHA and FCC. *A previous RSI RF Safety course is required to take this course.*  more...
Electrical Hazard Introduction to Electrical Safety. Discussion topics include: Hazardous Locations, General Safety Requirements, Electrical Hazards & Safe Working Clearances.  more...
Fall Protection 101 Introduction to fall protection within the RF working environment and general construction. Discussion topics include: Fall Protection Systems, OSHA Subpart M- walking / working surfaces, general ladder requirements and competent person requirements.  more...
Antenna 101 on-line e-learning cbt (computer based)study at homeself directed ...s employees are exposed too. Did you know the MPE safety requirements are based on frequency and the relationship of the wavelength to the body or its parts? The training will cover basic rules such as a the Higher the frequency the shorter the wavelengtha . It will also include how antennas work, antenna gain, beam width, loss, wavelength, and frequency. Several individual types of  more...
From Requirements Solutions Group
How to Plan Prepare and Manage Acceptance Testing instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises ...e 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 strategy, develop a test plan, organize test scenarios, and manage the testing effort for end-user acceptance testing based on business, stakeholder, solution, and transition  more...
How to Estimate Early in a Project - I+II instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises ...e you know what you are going to have to do to define the requirements. You have not yet done the analysis upon which to base your answer. Given that uncertainty, it is no wonder that whatever answer you come up with will be wrong, leading to a missed delivery date and unhappy customers. This workshop introduces methods that improve early estimates and the communication of the factors that  more...
How to Find and Build Test Cases from Business Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study Test cases are situations taken from real life that will put a new or modified information technology solution through its paces. Business test cases should be designed to find existing errors and to increase your confidence in the applicationa ™s ability to survive the real world of production. The key to a successful suite of test cases is to use a wide variety of methods to discover and  more...
How to Define and Document Use Cases instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study ...at information is critical to creating quality functional requirements. Without a common understanding of the purpose and structure of use case diagrams and the business use case document, use cases can quickly become "useless cases". This training workshop offers use case training in the basics of use case documentation and business use case diagrams as tools for business systems analysts.  more...
How to Analyze and Improve Business Data instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises Using business data model to identify potential business problems that are caused by missing or improperly defined business data is the next step in the progression from dataa asa aa problem to dataa asa aa valuablea resource. This on-line business analyst training workshop assumes you know how to draw business data models (entity/ relationship diagrams). It is designed to give you a  more...
How to Build Business Data Models instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises Business data represents the atomic level of information systems. It forms the basis upon which everything else depends. In a very real sense if you get the business data right, the rest will follow. If you get the business data wrong, the system may never recover. In order to get the majority of the business data right, it is essential to have a picture of the data in form of a business data  more...
How to Plan Business Analysis Activities and Manage Risks instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises ...e 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 idea. This virtual workshop focuses on the first half of techniques recommended by the International Institute of Business Analysis (IIBA ® in the Business Analysis Body of Knowledge (BABOK ®).  more...
How to Track and Monitor Business Analysis Activities instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study ... 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 workshop focuses on delivering techniques that will help the business analyst analyze stakeholder interaction on the project, use a RACI (Responsible, Accountable, Contributing, Informing) matrix to avoid problems before they  more...
How to Elicit Business System Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study ...w can you deal with these difficulties, gather reasonable requirements quickly, and not waste the effort? This training workshop offers techniques for determining how to gather, capture, elicit (whatever you want to call it) business requirements from subject matter experts. Whether you are preparing for a 1-on-1 interview or creating an email survey to get requirements, you will find a  more...
How to Write Effective Business Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study ...requirements is a critical skill for subject matter experts who represent the business interests on an IT project and for business analysts. The challenge lies in defining business needs in the form of business requirements, stakeholder requirements, solution requirements, and transition requirements that other audiences will interpret as intended and use to design the solution. This  more...
How to Analyze Sets of Business Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study ...requirements in the manner in which they were intended can be a very challenging proposition. If the requirements are going to do their job well, they need to be understood by several target audiences, namely the business community, the technical community, and the developer/ tester community. Each of these groups needs to be able to read the business requirements and extract what they need out  more...
How to Manage Changing Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises ...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 much  more...
How to Package and Communicate Business Requirements instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises ... experts. Business, stakeholder, solution, and transition requirements describe what information technology has to deliver but making sure that both parties agree on just what these requirements mean is the real challenge. This virtual workshop presents concepts, tools, techniques, and ideas for packaging, presenting, and communicating these types of requirements to both the business and  more...
How to Analyze and Improve Business Processes instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewarecase study, exercises Business process analysis is one of the most critical business analyst skills. It is the activity that uses business process models for improving business processes without putting your project a or your organization a at risk. This online business analyst workshop assumes you know how to create business process models (context, data flow, activity, and swimlane diagrams) and builds on that  more...
From TDM Webacademy
E104-7 Operations Management instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion A strategic foundation of a business marketing and sales 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  more...
E103-6 Operations Planning instructor led trainingon-line e-learning cbt (computer based)group study and discussion Often times, operations 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  more...
E103-7 Financial Planning instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion The wrap-up of preparing a business 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  more...
E103-2 Target Market and Industry Analysis instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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...
E104-2 Business Certifications instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion Description: The ability manages and control current and future expenditures means to implement sound fiscal management practices. This 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  more...
E104-4 Procurement Opportunities instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 instructor led trainingon-line e-learning cbt (computer based)group study and discussion 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 Global Innovative Campus
Design and Manufacture of Machine Elements Refresher Workshop 36 PDHs ...andidates on how to pass the APEGGA technical course exam requirements 07-Mec-A5, the delivery mode of this work shop is six consecutive Saturdays over six weeks, total of 36 hours from Saturday September 13 to Saturday October 18. This course is intended to provide the basic background to mechanical engineers, design specialists and technologists in the area of design and manufacturing of  more...
From THOMAS HOUSTON associates, inc
EE0-1 VETS 100100A Reporting instructor led trainingworkshop / seminar ...al contractor reporting EEO-1 & VETS 100/ 100A reporting requirements. Upon completion of this program the trainee will have an understanding of: Report requirements a who is required to file and when The difference between Vets 100 and Vets 100A On-line filing First time filing Extension requests Compliant methods for compiling data Why and when to survey  more...
From Healthcare and Medical Information Solutions
Health Information Technology Introduction instructor led trainingon-line e-learning cbt (computer based)courseware ...d in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic health record (EHR), and/ or health information technology (HIT) acquisition, use, and operations; or be a person who plan to take HIT Certification courses at their local college and/ or  more...
Health Information Technology Systems instructor led trainingon-line e-learning cbt (computer based)courseware ...d in their project. Although there are no educational requirements for taking our workshops or courses, it is recommended that individuals either have healthcare experience and participate in electronic health record (EHR), and/ or health information technology (HIT) acquisition, use, and operations; or be a person who plan to take HIT Certification courses at their local college and/ or  more...
From HR Learning Center LLC
MULTI-STATE EMPLOYERS TIPS FOR DRAFTING EMPLOYEE HANDBOOKS FOR ALL LOCATIONS Multi-state employers face many legal pitfalls when drafting their employee handbooks. Learn how to avoid these legal perils and ensure compliance with the state laws of the states in which you operate. This on-line interactive webinar will help you understand how to treat each state's legal requirements when drafting your employee handbook.  more...
From Expanding Thought
Tune Up Your Listening on-line e-learning cbt (computer based)group study and discussionworkshop / seminar 2 webinars, each 90 minutes webinar #1 builds awareness of listening habits and their impact on communication. Participants take the assessment instrument, Hear! Hear? Your Listening Portfolio that describes their use of four different listening habits. Participants examine how they prefer to listen, their listening strengths and challenges, and the appropriateness of their listening habits at  more...
From Webucator
Object-Oriented Analysis and Design (OOAD) Training with UML instructor led training ...aches students how to use object-oriented techniques from requirements gathering to implementation. Learn how to analyze and design classes and their relationships to each other in order to build a model of the business requirements. All the UML diagrams are covered in this OOAD class to identify the most suitable diagram suite for your organization. An emphasis is placed on Use Cases to  more...
MOC 5047 - Introduction to Installing and Managing Microsoft Exchange Server 2007 SP1 ...nage a messaging environment in accordance with technical requirements. Students will learn how to install Microsoft Exchange Server 2007 and manage routing, client access, and the backup and restore of databases. They will also learn how to manage addressing and recipient objects such as mailboxes, distribution groups, and contacts.This class is meant for IT Professionals, IT generalists, and  more...
MOC 5117 - Installing, Configuring, Troubleshooting, and Maintaining Windows Vista This Windows Vista training class provides IT Professionals who work in enterprise organizations with the knowledge and skills to install, deploy, configure, secure, maintain, and troubleshoot Windows Vista. This advanced course is aimed at enterprise desktop support technicians who want to gain an in-depth knowledge of Windows Vista.This class targets experienced IT professionals who focus on a  more...
From Manufacturing Executive Institute
Better Methods To Control Tools Fixtures in Production ...and fixtures. We will review tool and fixture maintenance requirements, including an innovative technique for scheduling and integrating tool and fixture preventive maintenance activities into production processes. We will also explore outsourcing opportunities in tool management and present some lessons-learned from manufacturing companies that have outsourced much of their tool management.  more...
How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ... 3. Learn what future information goes into a a Market Requirements Definitiona (MRD) document and how it should be created and maintained. 4. Learn how to better use past shipment data to more closely predict future shipments. 5. Learn the importance of acquiring current (or real-time), data in order to make appropriate short-term forecast adjustments. Participants in this montha  more...
Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ...ar, we will review high-level ABCA and ABL implementation requirements including: - The need for a commitment to eliminate ALL cost accounting distortions and product cost subsidies. - A need to be willing to know the cash contribution of every product and/ or service. - A need for a commitment to eliminate all non-value adding activities and begin a process reengineering journey.  more...
From GlobalCompliancePanel
New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities on-line e-learning cbt (computer based) ... on disclosures that you must honor. Learn about the new requirements for disclosers of health information to apply "minimum necessary" standards. Understand the new requirements for Business Associates to comply with HIPAA privacy protections and security safeguards and how BAs are subject to enforcement and penalties directly by HHS. Learn how Health Information Exchanges, Regional Health  more...
ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel 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. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST  more...
The 510k Submission Requirements Contents and Options - Webinar 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. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Safety Critical Software - Software Risk Management - Webinar By GlobalCompliancePanel Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Tuesday, February 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar By GlobalCompliancePanel This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Tuesday,  more...
Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...
DHF DMR DHR and the Technical File-Design Dossier - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, March 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Changes in the EU Medical Device Directives 2010 Modifications and the 2012 Recast of the MDD Directives -Changes in the EU Medi This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...dient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDAa ™s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed. At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the  more...
Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ...vices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard. Areas Covered in the Session: ISO 14971 compliance is a requirement of IEC 60601-1 The new standard uses risk management  more...
How to Survive a DEA Inspection Series For a Research Facility - Webinar By mentorhealth The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...
HIPAA Security Rule Compliance When Communicating with Patients Using Mobile Devices - Webinar By mentorhealth The session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...
Master Production Record Requirement - Webinar By GlobalCompliancePanel 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. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...
The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance  more...
Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Price  more...
Efficient Computer System Validation - 10 Easy Steps - Webinar GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...
Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...
Advanced HR Audit Techniques - Webinar By TrainHR ...at provides assurance that: 1) compliance and governance requirements are being met 2) business and talent management objectives are being achieved 3) human resource management risks are fully identified, assessed, and managed; and 4) the organizationa ™s human capital adds value. Under this definition, HR audits are more than an assessment that solely collects and presents evidence of  more...
Proper and Effective Handling of Child Support Garnishments - Webinar By TrainHR The information provided in this program will help the attendee accurately and completely process Child Support garnishment orders through the payroll department in compliance with federal and state requirements and regulations  more...
HIPAA Privacy Policies and Procedures Prepare for Updates and New Requirements - Webinar By mentorhealth Learn how having good policies and procedures and good documentation can make compliance easier. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...
Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel 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. Thursday, October 20, 2011  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...
Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...
Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...
The DHF DMR DHR and the Technical File Design Dossier - Regulatory Requirements - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, November 2, 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...
Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...
Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel This webinar will update personnel at medical device companies on the ISO 14971 standard and point them to the additional information available in the document under the informative annexes. The information will assist in meeting various national and global regulatory requirements for medical devices.  more...
How to Survive a DEA Inspection Series For Analytical Labs and Researchers - Webinar By GlobalCompliancePanel The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.  more...
How to Survive a DEA Inspection Series Controlled Substances and Hospitals - Webinar By GlobalCompliancePanel This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.  more...
Designing Drafting Writing and Implementing The Quality Manual his webinar will begin with a brief discussion about quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance  more...
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...
How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel ...requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is required from a DEA registered manufacturer or  more...
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ware". A manufacturer is responsible to identify these requirements and implement them into an effective 21 CFR Part 11 CGMP software V&V process. Why you should attend: Software has become pervasive in medical product manufacturing documentation and cGMP compliance actions, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,  more...
Effective Hazard Analysis to meet FDA and ISO134852003 Risk Management Requirements - webinar by global compliance panel FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle.  more...
Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...
Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.  more...
HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...
Validating Radiation Sterilization for Medical Device Industries by gcp ...d standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance.  more...
W-2s 1099s Independent Contractors Protect Yourself with Proper Classification by TrainHR Understanding proper classification requirements and helping to guide your company through this sensitive and important decision can be one of the most valuable and beneficial services that payroll departments can provide to the organization. Can you be relied upon to make those determinations correctly?  more...
Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products-GCP This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.  more...
Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements by GCP Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices  more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well  more...
ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...
Lyophilization What you Need to Know Validation and Regulatory Approaches by gcp This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.  more...
Document Retention and Destruction ...lar basis. This webinar will cover federal record-keeping requirements for confidential and sensitive human resource documents. Many state laws parallel Federal laws, but some State laws differ. You should refer to sources within all thestates in which you do business to assure full and accurate compliance. Some documents also may be covered under more than one law or regulation, so you should  more...
Tax Levies and Creditor Garnishments Maintaining Compliance and Eliminating Problems - By TrainHR This seminar covers the complexity in the handling and compliance with tax levies and creditor garnishments by the payroll department. Priorities between conflicting entities as well as federal and state compliance requirements are highlighted as well as tips for reducing processing time and costs.  more...
Root Cause Analysis and Documentation Requirements for CAPA - 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...
HIPAA and Electronic Health Records Meeting the new requirements and new regulations - Webinar By GlobalCompliancePanel The new and proposed HIPAA Privacy and Security regulations will be reviewed and their effects on the use of EHRs will be discussed. The proposed rules call for an ability to make an electronic copy of an individual's protected health information for any information held in an entity's designated record set.  more...
The Controls for Outsourcing Manufacturing and Testing - Webinar By GlobalCompliancePanel The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/ Procurement, Finance, and Senior Management. This webinar will study the outsourcing lifecycle and its impact on the  more...
ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel 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 firms  more...
Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin ...sing failures that keep us from meeting critical customer requirements in processes or products. It reduces product development costs operational risk. Join Dr. Anthony Tarantino, a Six Sigma Master Black Belt for an interactive session to learn how and when to deploy FMEA in your organization. He will also present an innovative means to combine FMEA with a new project prioritization framework  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...
Master Production Record Requirements - Webinar By GlobalCompliancePanel ...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...
Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  more...
Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  more...
Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied  more...
How to Survive a DEA Audit - Webinar By GlobalCompliancePanel this training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals.  more...
HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...ow they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary for compliance will be presented. Meeting any set of information security requirements always involves conducting a thorough risk analysis to make sure you haven't overlooked any weaknesses. We'll discuss what's involved and how it is the  more...
Analytical Test Methods Validation for GxP Laboratory Compliance FDA ICH and USP Requirements - Webinar By GlobalCompliancePanel This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation  more...
Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...l data, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation  more...
DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...view: 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 differences;  more...
HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...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 also in less obvious places such as copiers, printers, scanners, cell  more...
Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...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 provide up-to-date information on any expected changes. Attendees will learn what information is covered under the HIPAA and PCI rules and what are the ways the information should be protected, including  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 ... of a GCPa and how it is applied * The Regulatory requirements to follow to be GCP compliant * Who, in the clinical research team is responsible that GCP is followed? * How to be sure CPU / Site staff know their role in maintaining GCP Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry  more...
Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ... 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 application to all medical products. They will better understand the importance of their role not  more...
Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...ations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is  more...
Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...A LIFE cycle * Tools for each CAPA cycle * CAPA requirements * Tools for Preventive Action * Common FDA CAPA findings and how to avoid them Areas Covered In the Session: * Off-label statute * Label claims * Allowable reprints * Promotional compliance * FDCA: The law Who will benefit: * Sales executives in Medical Device *  more...
Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...System A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries.  more...
Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ss, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate  more...
Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ...ns - FDA, Canada & Europe * FDA's complaint handling requirements * Canada & European Union complaint handling * FDA's voluntary & mandatory reporting * 21CFR 803, 806 & 810 explained * FDA regulatory actions against firms * Adverse event reporting - Canada & Europe Who Will Benefit: * Design Engineers * Regulatory Professionals * Technical  more...
Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...liance * Review of the regulations * Regulatory requirements * Site Inventory * Compliance Assessment * Risk Assessment Who Will Benefit: The employees who will benefit include: * End-users responsible for applications that need to be validated * QA managers and personnel * Information Technology managers and personnel * Validation specialists  more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...d in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR) o Definition o Typical contents  more...
The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ncy intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V)  more...
Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...essment 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 ways to conduct a security risk analysis to meet the requirements of HIPAA and the "meaningful use" rules. It will also provide examples of checklists and  more...
Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...ple to discuss what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation effort will be explained and the elements of the Validation effort will be outlined. Change Management will also be discussed, with regards to how Vendor changes and customer configurations affect the validation and the testing that will be  more...
Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...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 ...agement Tool, Test Management Tool Operation/ Maintenance requirements and Automated Testing considerations. Areas Covered in the Session: * System Based Test Tools vs. Paper Based Test Tools * Paper Based Validation Practices vs. System Based Test Tools * Test Management Tool Implementation Considerations * Test Management Tool Usage Considerations * Automated  more...
Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...overed in the Session: * Operational lab equipment requirements for calibration and qualification * Most common inspection problems * USP Chapter : Analytical Instrument Qualification * Development of an effective equipment qualification master plan * Calibration/ qualification phases: design qualification, installation qualification, operational qualification,  more...
Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...emselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. 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. Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now  more...
Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...nel who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. Why you should attend: The Learning  more...
A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...F, ISO particularly ISO 13485 as well as European quality requirements. The considerable use of graphical techniques will enhance this learning experience. Questions are strongly encouraged. Areas Covered in the Session: * Module 1 - Introduction to Quality and Compliance Concepts * Module 2 - Differences between Medical Devices and Pharmaceuticals * Module 3 - Scope of the  more...
Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ... It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition status. The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or  more...
Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...rgency rooms and surgical areas. * DEA Recordkeeping Requirements: This section covers the required records to be maintained in order to comply with DEA regulations. Records include receiving/ shipping order forms and invoices, inventories, drug destructions, and theft/ loss reports. * DEA Security Requirements: This section covers the steps that a hospital can take in order to be in  more...
Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ... seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective implementation. Reference material for easy implementation: * SOP: Retrospective Validation of Computerized Systems * Checklist: Retrospective Validation of Computer Systems Areas Covered in the Session: * Definition of legacy systems  more...
HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...reas Covered In the Seminar: * Learn about the new requirements for HIPAA Business Associates * Find out what has changed for Business Associates * Learn how the definition of BA has been significantly expanded * Learn what goes into a proper Business Associate Agreement * Find out about the new, higher enforcement penalties * Learn about the new violation  more...
Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...eers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the paper trail you are required to maintain to show compliance. Compliance regulations are released by regulatory bodies throughout the product's life cycle. It is a requirement for the manufacturer of  more...
Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel ...d 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. Areas Covered in the Session: * Complaints Definitions; FDA, EU & Canada * How to Document Complaints & Adverse Events * US & Foreign  more...
Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ...ew: 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 certification  more...
Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...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 characteristics of the Risk  more...
FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...rities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new technologies. No one involved in process development and validation in the drug, API, or biologics industries (or their vendors!) can afford to miss this presentation; while  more...
Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...d to replace. Topics will include the development of 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)  more...
Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ...ed validation approach to lower costs. * How to link requirements, specifications, risk management, and testing. * Document a computer system validation project using easy to understand fill-in-the-blank templates. * Based on: "Risk-Based Software Validation a Ten Easy Steps" (Davis Horwood International and PDA - www. pda. org, 2006). * Step-by-step instructions for  more...
Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...ss must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also  more...
Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...e 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 this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one should  more...
Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...egulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices. Why you should attend: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it  more...
Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...view: 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 ...ctive 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 should attend: The  more...
FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...ice company and list your device(s) correctly and meeting requirements and expectation regardless of the outcome of the Proposed Rule. Areas Covered In the Seminar: * When and how to register and list * Review the four proposed changes to FDA's device establishment registration and device listing regulations * Proposed changes to Implement the provision of Bioterrorism Act  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 ...CT number in accordance with the Clinical Trial Directive requirements * Start to prepare the outline plan for the study using the work breakdown structure (WBS) technique, outline Gantt chart with estimated timelines for main activities of the study * Identify possible project risks and uncertainties. Prepare a risk register to handle risks a develop contingencies and how you can  more...
Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ulatory "Hot Buttons" * Classify suppliers; Supplier requirements by "classification" * What's behind the COA? The COC? * The FDA's increasing emphasis on the site audit * Types of remote audits * Maintaining the relationship Who Will Benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D *  more...
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...processes, found in 21 CFR 820. 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.  more...
Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...s 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 * Minimize nonconformances  more...
Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...e system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a  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...
Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...iate + The regulations and international requirements for CAPA and the clear understanding how to suit your procedures, work instructions and forms to address it * Module 2 o Examples of problem solving tools, management tools and measurement tools, which are great for identification of the true root cause(s) of the issue o These tools also used for  more...
Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...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 devices. Why should you attend: Any firm reprocessing  more...
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...ms can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to  more...
Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...ist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning and Realization of Safe  more...
Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ... as a prescription. The inspection targets record-keeping requirements, security of all controlled substances, and review of dispensed prescriptions. Class participants will familiarize themselves with federal laws and DEA regulations requirements for handling of Schedules II though V controlled substances in a pharmacy setting and the record-keeping and security responsibilities placed on  more...
Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel ...s on general labeling provisions for dietary supplements, requirements for inner and outer packaging, and claims made on e-commerce websites. Why should you attend: * Avoid product recalls * Be in compliance with labeling requirements * Avoid wastage in regulatory fines * Improve your profitability Areas Covered in the Session: * Labeling defined *  more...
Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...ftware V&V Expectations * Key COTS Software Apps V&V Requirements * Problem Areas * Product, Equipment/ Process, QMS and Apps Software and Part 11 Requirements * Realistic Limits of Apps Software V&V * Suggested Approaches * How to Implement, Execute and Document * Proper Risk Allocation of Scarce Resources Who Will Benefit: * Senior management in  more...
Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...anies to manage projects formally - to include regulatory requirements, design and/ or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to  more...
Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ners or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include  more...
Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...nd methods to form a social media policy that meets these requirements. Why you should attend: Some healthcare providers want to engage social media marketing, but are afraid of the risks. Some are active in social media, and are not aware of the risks. And some simply need to ensure that they are focusing on the correct risk areas and structuring their social media activities in ways that  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 ...ustomizable course for personnel to meet program training requirements. Why you should attend: Recalls for chemical contamination can be costly to an organization injuring consumers and damaging the brand and its sales. Hundreds of opportunities for accidental and intentional contamination can occur in even the best operations. Proper chemical control can minimize risk, resulting in better  more...
Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...ems 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 should be risk-based. The presentation will give an example of how to develop a risk-based CAPA system. Why should you attend: In  more...
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...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 deviations. Participants will obtain a greater  more...
Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...lementing 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 submissions accepted by FDA - mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug  more...
Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...mpliance project Agenda: * Information Security Requirements Under HIPAA o The Regulatory Background of HIPAA o Overview of Security Requirements o Recent Changes to HIPAA Security Requirements o Structure of the HIPAA Security Regulation * The Security Rule Compliance Process o Concepts of Compliance with the Security Rule  more...
Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel ...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 leave a lot of room for  more...
Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...status of the electronic system and describe the upcoming requirements for manufacturer reporting. Why should you attend: Medical device manufacturers continue to have problems with the MDR regulations and reporting of potential adverse events and possible device malfunctions. The regulation has been unchanged for several years, but FDA continues to find violations of these regulations. Both  more...
Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...resent simple and effective strategies for satisfying the requirements. The impact of USP on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed. Why should you  more...
Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...d maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on Harmonization (ICH) and the Global Harmonization Task Force (GHTF) guidances. The attendees will quickly learn  more...
How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources  more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...d in the Session: * FDA Quality Systems Regulation Requirements/ Definitions * MDD Requirements/ Definitions * Design History File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR) o Definition o Typical contents  more...
New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...he American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement activity. All kinds of covered entities, and now,  more...
Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...cility. This session will address the latest FDA guidance requirements and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device. Plus, FDA understands that manufacturers will have different tracking methods and procedures. Areas Covered In the Session: * Review the key provisions in the updated FDA guidance  more...
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...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 methods by which  more...
Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...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 a great extent, but not completely.  more...
101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...al expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/ RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent  more...
The Process Approach to Auditing - Webinar By GlobalCompliancepanel ...se 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: * Management of the Quality System * Top management involvement * Customer focus  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...
Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ... 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. It will  more...
Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...el, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the applicable US and EU expectations of documentation plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena. According to the FDA, if  more...
HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ...fice. Beyond the use and disclosure provisions, there are requirements for allowing individuals to have access to their medical records and even asking for changes to their records or asking to have special restrictions placed on their records. If you want to use health information for some other purpose outside of treatment, payment, or healthcare operations, you may need to have the patient  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 ...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 contained will be a suggested  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...
Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...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 establishment of a training  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...
Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...alth and safety of your customers, comply with regulatory requirements/ laws and protect the image and reputation of the company and its products. This presentation will help you to have a basic idea how to develop an effective crisis management program for product recovery and product recall. Many crisis situations can ruin your business in a short period of time when it took a longer time to  more...
GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel ...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 Food, Drug, and Cosmetic Act. Thus the  more...
The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...ncy intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V)  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...
Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...ions for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/ or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device  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 FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major 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  more...
Regulatory Complaint Handling MDRs Recalls - Webinar by GlobalCompliancePanel ...e complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and has even driven the firm's stocks down. This presentation will review the regulations and  more...
Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ... to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework  more...
The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel ...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 compliance  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 ...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 perspective will be  more...
Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to  more...
Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel ...requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit program, your company needs an effective  more...
How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel ...FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel  more...
The FDA Tripod - Clinical Trial Regulations Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel ...w of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information  more...
Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ...ul validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk  more...
Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel ...literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need for control  more...
Signal Detection and Data Mining - Webinar by GlobalCompliancePanel This webinar will cover the fundamentals of signal detection, and how these can be augmented by the use of data mining techniques. In March 2005, the FDA published final guidance on "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." This guidance defines the FDA's views on pharmacovigilance concepts, safety signal identification, pharmacoepidemiologic assessment and  more...
Verification of Pharmacopeia Methods - 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 and  more...
The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...
Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...ation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents. The FDA issued the Medical Device Quality Systems Manual to help companies implement the  more...
Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products  more...
A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...
Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel ...is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review,  more...
Pharmaceutical Manufacturing Batch Record Review - Webinar by GlobalCompliancePanel ...entation include: * Recognize regulatory (FDA/ EU) requirements for batch records and batch record review * Modeling best practices of a technical review of batch records * Discover the essentials of batch record reviewer qualifications and training * Acquire confidence in determining the final decision or recommendations. * Establish a working relationship between  more...
How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel ...DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these products, you will get a better understanding  more...
Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give  more...
From XA Systems
ITIL Foundation Bridge Virtual Classroom Take the ITIL ® v3 Foundation Bridge course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This 2-day course introduces learners to the lifecycle of managing IT services to deliver to  more...
ITIL v3 Foundation Virtual Classroom Take the ITIL ® v3 Foundation course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This exciting and dynamic 3-day course introduces learners to the lifecycle of managing IT services  more...
From GlobalCompliancePanel
Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...
Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...
PCI Data Breaches What happened What may have prevented it What if it happens to you ...requirements for PCI, you're in good company. Unfortunately, in this case there is no safety in numbers. Criminals do not necessarily attack big companies; they go after whatever is easy. The cost of responding to a breach is getting more expensive each year. In this webinar you will learn about the current threat environment, how some of the biggest data breaches of recent years could have  more...
New Requirements for the Medical Device Directive MDD ...lCompliancePanel brings a new webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at  more...
The 510k Submission Requirements Contents and Option ...ings a new webinar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate  more...
From University of Kansas Continuing Education
Process Instrumentation and Control Online Certificate Course ...low, level, pressure and temperature measurements. 4. Requirements for control rooms and the design of control panels. 5. Concepts and implementation of alarm and trip systems. 6. Different types of computer-based control systems, including PLCs and DCSs, as well as basic requirements for good operator interface. 7. Documentation required for I&C for front-end engineering and  more...
From ProfessionalOrganizers . com
Do I E-Shred This on-line e-learning cbt (computer based)study at home This webinar is a primer on handling electronic information. Learn how it's stored (not too technical, I promise!) and where it resides. Learn the 10 privacy principles that form the basis for most privacy legislation and how to use them as part of your or your client's environment. If you or your clients store electronic information, and almost all do, it's critical to include handling  more...
Records Management 4 - Records Management Software - On-Demand Webinar This webinar is the 4th in the series and it examines how the use of the proper software can greatly enhance the programa ™s effectiveness and reduce a lot of the more tedious, time consuming tasks associated with managing information. It will also cover the range of software options and how to develop and manage the process for developing system requirements and choosing the right solution.  more...
From Total Medical Compliance
Basics of Fraud Abuse Complimentary Webinar ...as she discusses the basics of fraud and abuse compliance requirements. At the end of the session each learner will be able to: Define Fraud and Abuse a it is not always intentional. Recognize pertinent federal and state laws related to fraud and abuse a intentional or not. Explain the importance of a Compliance Plan and how to determine the effectiveness of the plan. The time  more...
From HOOD Group
HOOD CPRE E-Learning -Certified Professional for Requirements Engineering - Foundation Level on-line e-learning cbt (computer based)study at homeself directed ...re for the certification examination of the International Requirements Engineering Board. The online training course has been developed by experts in requirements management & engineering, who have been significantly involved in producing the syllabus and examination for the "Certified Professional for Requirements Engineering (CPRE)" qualification and who are experienced in preparing  more...
From Avant Resources
FCPA and Global Anti-Bribery Compliance ...ct (FCPA) and other international anti-bribery laws; The requirements of the FCPA, the U. K. Bribery Act 2010 and other global anti-bribery laws; Ways your company and executives can avoid huge fines and possible jail time Practical suggestions to implement an effective compliance program at your company Who Will Benefit from this Webinar: Compliance officers Executive management  more...
From TrainHr
Payroll Best Practices Proper Handling of Multistate Taxation - Webinar By TrainHR Complying with the tax code, tax withholding requirements and deposit schedules for the IRS and one state is complicated enough. But for the multistate employer multiply this by 5, 10, or 20 or even 50 and it can turn into a payroll department's worse nightmare. Not only more rules and regulations to comply with but you must multiple the penalties if you make as mistake as well  more...
From CompliancePanel
Regulatory Complaint Handling Vigilance Recalls 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...
From iGallant Solutions
Six Sigma Green Belt SSGB ...ynamics. a VOC, a Customer feed back, a Customer requirements, a Project tracking. Measure a Process analysis and documentation a Collecting and summarizing data. a Probability and statistics a MSA a Process capability. a SIPOC a Data conversions, a Sampling methods a Develop data collection plan a Process flow Metrics tables, WIP, takt time, cycle  more...
From Clinical Solutions Medical Training
HIV AIDS Course ...rovide students with the opportunity for completing their requirements of the Florida Status Requirements 381. 0035: the requirements for Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome. This self-study program will enhance the learnera ™s knowledge about HIV and AIDS by: 1. Teaching the learner the facts of HIV and AIDS 2. Preventing the spread of the disease 3.  more...
From Obiee Online Training
Obiee Online training Interactive ...3rd class. I will explain you the real time requirements in OBIEE at clients place so it will be easy for you after joining the first job. I will give you Introduction to Informatica and DAC financial analytics which are advanced topics in OBIEE, which will help you getting a job very easily. Last but not least, teaching OBIEE is my passion, I do not  more...
From Pilot Performance Resources Management Inc.
Food Safety Management Systems - ISO 220002005 instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareworkshop / seminar On line webinar covering standard requirements for Food Safety Management to ISO 22000: 2005  more...
Environmental Management Systems - ISO 14001 instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareworkshop / seminar How to Implement. ISO 14001 Standard Requirements. On-site or on-line. Pre-requisite to Auditor Training - ISO 19011. www. pilotims. com  more...
From Global BioPharmaceutical Resources, Inc. (GBPR, Inc.)
21 CFR Part 11 the details of what it means ...requirements of Part 11 and details them into specific things to do in all three primary areas: SOPs, product features, and validation. It describes what to do to be compliant thereby avoiding 483s and warning letters. All required IT SOPs are covered. All industry standards product features are discussed. The 10-step risk-based validation approach is outlined so that the specific documents for  more...
From International Trade Center
NAFTAFree Trade Agreement Training Certification FTAs can be beneficial to your business as long as you know the rules. Topics include: NAFTA 101 & Rules of Origin, NAFTA Requirements: Canada, NAFTA Requirements: Mexico, How to Complete a NAFTA Certificate of Origin, Current and Pending FTAs: Their Requirements and Benefits. Certification by NASCO upon completion of both days. November 10, 11, 2010. Webinar 8 am-3: 30 pm $240 for both days.  more...
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