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C A Process Training Seminars and Classes
From Certified Foreclosure Agent Program
FREE Short Sale Fundamentals 101 on-line e-learning cbt (computer based) Long, complicated and costly a the list of adjectives that real estate agents often use to describe the short sale process is almost always anything but "short." The good news is times are changing. There are numerous ways in which you can cut the time in half, get your offers pushed to the top of the stack and do very well with short sales. All it takes is the inside knowledge of how to  more...
From Discovery Detective Academy
Attorney Legal Professionals CLE Brown Bag Series First Wednesdays Brown Bag CLE webinars. 12: 30 -1: 30 pm. Approved Continuing Legal Education units given for Attorney's & Legal Professional's. Eat your lunch while learning and get 1 CLE. Topics to include are: Problems to avoid in Adoption Reunions, Asset Recovery what can be done, Approaches to directing a difficult Process Serve, Internet sources... Check our online calendar  more...
From Sql Server Online Training
MSBISSIS SSAS SSRS 2012 Online Training SQL School SQL School, one of the best places for SQL Server PRACTICAL training provides Microsoft business intelligence [MS BI] course with one REALTIME PROJECT. Course Duration is for minimum of 70 hours, completely practical and covering SQL Server Integration Services [SSIS], SQL Server Analysis Services [SSAS] and SQL Server Reporting Services [SSRS]. Please find the Course Highlights: SSIS a  more...
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 Kepner-Tregoe Inc
Live Webcast Thinking Correctly Under Pressure instructor led trainingon-line e-learning cbt (computer based) Thinking Correctly Under Pressure (TCUP) continues to gain more and more attention in companies that are committed to the idea of Service Excellence. The ability to "stay cool and focused" when the situation at hand gets hot is something that is required whenever we look at Incident Management, but could also be transferred into any other environment where effective decision making and proactive  more...
From Requirements Solutions Group
How to Build Business Process Models instructor led trainingon-line e-learning cbt (computer based)group study and discussioncoursewareexercises, case study Business processes are what organizations do. Whether documented or not, whether designed or not, whether understood or not, nothing gets done until someone (or a the systema ) does it a that is what business processes are all about. They are a combination of business operating procedures, business rules, business data, and supporting technology. Yet, many business processes are undocumented,  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
E101 Entrepreneurial Spirit Within instructor led trainingon-line e-learning cbt (computer based)group study and discussion Description: Many successful entrepreneurs have stated that the desire to own a business has always been a dream. So a very young age they started to small ventures such as lemonade stands, cutting lawn and, shoveling snow. At a very young age these individuals was cultivating the knowledge and skills necessary to become a successful entrepreneur. Objectives: This webinar explores those  more...
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...
From Resources Unlimited
Practical Meeting Facilitation Techniques instructor led training Whether you conduct in-person meetings or virtual meetings, teams need your assistance to move quickly toward project and process goals. Register today for a Practical Meeting Facilitation Techniques Webinar to learn how to prepare for your next important meeting. Learn how to generate more ideas, how to gain participation from everyone in your meeting, and how to converge on ideas that have  more...
From Spectralight Images, LLC
3DS MAX Online - Lighting and Rendering with Photometric Lights instructor led trainingon-line e-learning cbt (computer based)group study and discussioncomputer lab This online course will take you through the process of lighting your scene using photometric lights in 3DS MAX & Design 2010. In this course you will learn how to set up and configure lighting for your scene, learn the parameters associated with photometric lights and use IES data to enhance the realism of the lights in your scene.  more...
3DS MAX Online - Rendering with Mental Ray instructor led trainingon-line e-learning cbt (computer based)group study and discussion For most forms of animation, rendering an image the the most critical step in the process. This online course will take you through the various options available when using Mental Ray to render in 3DS MAX & Design 2010. You will learn about the options available for optimizing render time and image quality, using indirect illumination and working with several new features available in release  more...
From Black Box Consulting
Xilinx FPGA Academy II - Intermediate instructor led trainingon-line e-learning cbt (computer based)bookcomputer lab This 5 day course is for designers with a few projects under their belt to the experienced. Here we get insdie the FPGA and get you thinking about what you right in code and what gets created in actual hardware. This thought process is the foundation of a good designer. We address the Slice in indepth detail, we discuss memory types, carry chains, LUTs, synchronous design techniques, using  more...
From Optivation
How to Hire the RIGHT Person for the job Through this course you will learn how to create a new position or fill an existing one. This course will help you analyze your businesses needs and walk you through the entire hiring process. Throughout the course you will develop a job description, improve your job application, create an ad you can use to advertise your job position, walk through the interview process-creating job appropriate  more...
From International School Of Body Art
learn how to body pierce on-line e-learning cbt (computer based)study at homecd rome-bookDVDbookcomputer lab Do you have the drive, the determination and the willingness to learn? Then we can help make those dreams a reality! The Body Piercing learning process is not an easy one. There is a lot to learn and getting a good apprenticeship can be very costly, what I am offering is a chance to get a helping hand in the apprenticeship learning battle. I am a Body Piercing artist of 9 years. I have been  more...
From Future Media Concepts
InDesign Complete - Online on-line e-learning cbt (computer based) Adobe InDesign software speaks the language of professional designers, delivering unparalleled creative freedom, productivity, and precision for designing superb pages. It works seamlessly with Adobe Photoshop and Adobe Illustrator, providing a single integrated design environment that doesn't interrupt your creative process. InDesign even opens Quark XPress and Adobe PageMaker files, so you can  more...
From ITpreneurs
ITIL v3 Service Offerings and Agreements Capability SOA Course Description - This 5-day course immerses learners in the practical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Service Offerings and Agreements of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on  more...
ITIL v3 Operation Support and Analysis Capability OSA This 5-day course immerses learners in the practical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Operational Support and Analysis of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This  more...
ITIL v3 Planning Protection and Optimization Capability PPO This 5-day course immerses learners in the practical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Planning Protection and Optimization of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This  more...
ITIL v3 Release Control and Validation Capability RCV This 5-day course immerses learners in the practical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This  more...
From People Biz Inc.
Hiring Plan Webinar HIRING PLAN | Thursday, November 10, 2011 | 2: 00 PM a 5: 00 PM CST Led by Alicia Marie How do you know when it is time to hire? What role is the right one? Identify a strategy for building your organization as well as a hiring process for identifying talent. Save time, money and the headache of a bad hire. Register Here:  more...
Inspired Goals Webinar YOU WILL LEARN: a The top three reasons why people dona ™t set goals a How to start fresh and complete past goals a The process of focus and attention a Goal setting tips a The language of goal setting a Strategy for what will likely stop you from achieving your goals a How to set goals that inspire and motivate a How to embrace failure and  more...
From Aptero Solutions
Webinars instructor led training Online, educational sessions, describing and demonstrating key techniques and approaches to the analysis of business process and systems. Topics covered will include (in different sessions): Business Process Modelling Notation (landscapes and workflows), Unified Modelling Language (primarily use case, activity and class mdoelling), Data Modelling (entity relationship and physical schema  more...
From Camo Process AS
Multivariate Data Analysis for Spectroscopy Applications Web Workshop This workshop has been designed to give participants a strong foundation in the basics and fundamentals of Multivariate Data Analysis and its applications for spectroscopy data. In this training you will learn how to pre-process your spectral data. You will also learn how you can interpret the Principal Components Analysis (PCA) and Partial Least Squares (PLS) loadings as signal.  more...
From UC San Diego Extension Digital Arts Center
Learn Web Design with UCSD Extension Digital Arts Center This course teaches designers how to move from a static to dynamic website using jQuery, JavaScript, MooTools, Flash banners and galleries, and CSS3. This is the second course in our Web Design Skill Series. Through the series, students will learn to hand-code their own websites. The first course in the series explains the hand-coding process, the second takes students from static to dynamic  more...
From HR Learning Center LLC
MANAGING LEAVE OF ABSENCES PART II - ADA The Americans with Disabilities Act is complicated, legalistic and difficult to administer. Managers often make major mistakes when they do not understand that the employee is requesting a reasonable accommodation or that they have an obligation to engage in the "interactive process". Moreover, managers also sometimes fail to understand that even granting an additional leave of absence can be  more...
HR BOOT CAMP FOR MANAGERS Managers often get promoted to be a manager with no formal training on how to manage to ensure legal compliance. This nut and bolts how-to on-line HR Bootcamp webinar will provide your managers will everything they need to know to prevent liability in your workplace. Train your managers with HR Bootcamp on the employment discrimination laws including Title VII, ADA, ADEA, FMLA and how to  more...
HIRING DOS AND DONTS instructor led trainingon-line e-learning cbt (computer based) This one-hour on-line live interactive webinar will provide managers with top tips to avoid liability when hiring employees. Learn what questions you can and cannot ask during the interview process. Learn how to avoid asking questions that can lead to discrimination claims later on. Also, learn what employment-at-will really means and how to avoid losing your right to hire or fire at-will. Learn  more...
LABOR RELATIONS TRAINING One of the most difficult things for managers to do is to manage effectively in a represented environment. This is all the more true when your managers, who were used to managing in a non-represented environment, all of a sudden have to deal with labor relations issues for the first time. We will assist your managers in dealing effectively with the labor relations process and will provide an  more...
From KAS Training & Development
Legal Word Processing Course - Microsoft Word 2007 instructor led trainingon-line e-learning cbt (computer based)group study and discussionworkshop / seminartrain the trainercomputer lab This comprehensive course focuses on the core formatting elements of Microsoft Word 2003, 2007 or 2010. It provides conceptual and technical learning of the software's advanced features used by international law firm staff to process complex legal documents. The KAS Training Legal Word Processing course was developed by legal trainers with more than 20 years of experience in the legal industry.  more...
From The College of Call Center Excellence
Call Center Workforce Management Certification - Live Online - August 1-3 2012 on-line e-learning cbt (computer based)study at homeworkshop / seminar The BenchmarkPortal contact center Workforce Management Certification training course for workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just  more...
Call Center Workforce Management Certification - Live Online - April 4-6 2012 on-line e-learning cbt (computer based)study at homeworkshop / seminar The BenchmarkPortal contact center Workforce Management Certification training course for workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just  more...
From R-square Systems Inc
Documentum E20-120 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...
Documentum 65 Training on-line e-learning cbt (computer based) This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...
From Webucator
QuickBooks 2009 Training This Quickbooks training class covers the fundamentals of using QuickBooks 2009 to track the finances of a small business. Students will learn how to set up a new company, work with lists, set up inventory, process invoices, work with bank accounts, process payments, enter and pay bills, and use online banking. In addition, students will learn how to customize forms, create reports and graphs,  more...
MOC 8812 - General Ledger in Microsoft Dynamics GP 10.0 In this Microsoft Dynamics GP training class, students learn to set up General Ledger, to enter and post transactions in General Ledger, to use Multidimensional Analysis, enter Intercompany transactions and set up Organizational Structures to use account security, to maintain General Ledger records, and to learn the process of closing an accounting period and the fiscal year.  more...
MOC 8819 - Payables Management I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Payables Management training class examines the accounting cycle and the processes required to enter vendor invoices and process checks. This class also shows how to perform additional functions such as adjustments, prepayments, month-end closing, and cash flow control.A thorough understanding of these topics allows for capitalizing on vendor discount dates to reduce  more...
MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Sales Order Processing class explores the accounting cycle and the processes required to enter and ship sales orders. This class shows you how to easily manage the life-cycle of your customer ' s order from the initial quote to the shipment documentation and final invoicing. You learn how to perform additional functions setting up process holds for quality assurance and  more...
MOC 8399 - FRx 6.7 Report Design Essentials I This Microsoft FRx training class covers the basic report design skills you need to create, maintain and distribute presentation quality reports using Microsoft FRx. The class also includes coverage of additional functionality designed to help you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations,  more...
MOC 8400 - FRx 6.7 Report Design Essentials II This advanced Microsoft FRx training class builds on the basic report design skills learned in MOC8399. Using Microsoft FRx you learn advanced report design including linking to external worksheet data, linking row formats, multi company consolidations, currency translation reporting and cash flow. A combination of instructor guided exercises and practice tutorials allow students to master their  more...
MOC 8671 - Bank Reconciliation I in Microsoft Dynamics GP 10.0 The Microsoft Dynamics GP Bank Reconciliation training class explores the accounting cycle and the processes required to manage cash receipts, cash disbursements, and other transactions that affect checkbook balances. This class shows you how to perform the reconciliation process, ensuring accuracy of your financial data and its relation to your financial institution.A thorough understanding of  more...
MOC 8811 - Foundation I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Foundation training class explores the basic elements of Microsoft Dynamics GP. Topics covered during this session include: system and company setup procedures, how to use reports and inquiries, how to use SmartList to expand inquiry and analysis capabilities, business alerts, process server and tips for the user to personalize shortcuts and checklists to streamline  more...
MOC 3938 - Updating Your Skills from Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 to Microsoft Exchange Serv This Microsoft Exchange training class targets Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 administrators who need to upgrade their skills to manage a Microsoft Exchange Server 2007 infrastructure. This class focuses on the new features and administrative tasks in Exchange Server 2007.Students will learn skills that enable them to deploy and manage an Exchange Server 2007  more...
Business Ethics Training This Business Ethics training course introduces students to the fundamentals of business ethics. Students learn about the decision-making process to solve ethical dilemmas, understanding barriers and consequences when making ethical decisions, and the process for blowing the whistle when unethical situations arise. Course activities also cover identifying common managerial ethical issues, being  more...
Introduction to ColdFusion Training instructor led training This is an introductory ColdFusion class for Web designers who are brand new to ColdFusion. You will learn to process forms, manage sessions, write reusable code and create database-driven ColdFusion-based websites.  more...
Change Management Training This change management training course teaches students how to develop the skills to proactively address change and meet the challenges of transition in the workplace. Students will work with various employees to overcome the problems encountered when making changes in your organization. Students will also learn how to develop the ability to effectively handle organizational changes by examining  more...
Business Problem Solving and Strategic Decision Making This Business Problem Solving training course teaches students the fundamentals of solving business problems. This course introduces students to the need for problem solving, ineffective responses to problems, the elements of an effective solution, and the skills needed for effective problem solving. Students will also learn how to avoid inappropriate responses to problems, identify types of  more...
Introduction to Active Server Pages instructor led training In this ASP training course, students will learn to build full-featured, database-driven Web sites. This introductory course for new programmers lays out the basics of server-side Web programming with an introduction to classic programming structures and good programming practices. Students will apply these programming skills to the development of a fully functional data-driven website with ASP  more...
Managing Performance Training This Managing Performance training course teaches students the basics of creating a performance plan and the appraisal process. Students will learn how to conduct a performance-planning meeting, document the performance plan, provide positive and constructive feedback, coach employees during the appraisal period, appraise employee  more...
Project Management Training This Project Management training class teaches students project-management techniques, including managing time and costs. Students will identify the features and attributes of a project, the steps and variables of the project management process, the effects of environmental, socioeconomic and organizational structure issues, and the responsibilities of a project manager. Course activities also  more...
Motivation Training In this motivation training course students will discuss the foundations of motivation. They will examine motivating and demotivating factors as well as negative thoughts. They will also discuss motivation theories and the benefits of motivation. Students will examine the concept of having a Positive Mental Attitude, and how they can work towards a PMA in their lives. During this course, students  more...
From Manufacturing Executive Institute
Implementing Statistical process Control SPC for Short Run Production You are invited to attend the Manufacturing Executive Institutea ™s August 16th 2012 3rd Thursday - a Operations Improvement Seriesa FREE webinar, a Implementing Statistical Process Control for Short-Run Production.a SPC has helped many manufacturing companies achieve world class quality in production operations. Application of SPC techniques have become commonplace and a normally  more...
A Case for Routine Use of Statistical Process Control SPC in Manufacturing You are invited to attend the Manufacturing Executive Institutea ™s FREE June 2012 3rd Thursday - a Operations Improvement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can  more...
A Better Method for Cross Training Production Personnel You are invited to attend the Manufacturing Executive Institutea ™s August 2009 3rd Thursday - Operations Improvement Series FREE webinar, A Better Method for Cross-Training Production Personnel. Companies that take cross training of production personnel seriously report as much as a 30% fewer direct labor employees than exact peer companies. They also report faster cycle times, higher  more...
How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs Supply-chain professionals must NEVER stop thinking about the integrity of the shipment forecast. This is because a shipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will  more...
Understanding Improving Yields Scrap Rework Scrap and yield are different measurements that tell us different things about our production processes. Measuring and monitoring them precisely (and individually) is an important component of any process improvement initiative. If these values get comingled in the measurement procedures, underlying root cause analysis is certain to result. This FREE 1-hour webinar presents the CORRECT  more...
From Pix Software
JIRA Workflow Administration Webinar on-line e-learning cbt (computer based) The JIRA Workflow Administration training course covers all administrative features of JIRA related to customisation of the workflow and data capture. Attendees from this session will become proficient with creation of custom fields, new issue types, workflow statuses, transitions, post functions, field configurations, mandatory fields, hidden fields, workflow schemes and applying a JIRA workflow  more...
From Manufacturing Executive Institute
Better Methods for Maintaining Accurate Operation Standards The Manufacturing Executive Institute is pleased to bring you this LIVE & FULLY interactive "Virtual Classroom" workshop on Tuesday, May 10 at 10: 00 AM PDT. Participate in this virtual training event from the comfort of your office or home computer. Learn from an expert instructor AND your industry peers! Manufacturing professionals ALWAYS worry that production operation standards are  more...
Constructing a Component Criticality Matrix A Better Way to Identify Important Components Procurement organizations are often responsible for managing thousands of parts that can be purchased from hundreds of Suppliers. The large number of parts and Suppliers makes it nearly impossible to manage each individual part as much as one wants to. This is why Procurement organizations rely upon stratification methods and other sorting methodologies to provide insights into GROUPS of parts.  more...
How to Achieve Maintain ERP Systems Master File Data Integrity You are invited to attend the Manufacturing Executive Institutea ™s May 19th 2011 3rd Thursday - a Operations Improvement Series FREE webinar, How to Achieve & Maintain ERP Systems Master File Data Integrity. Contrary to the popular belief that modern, fully-integrated information systems provide executives with the tools to make more effective and efficient decisions, there is increasing  more...
Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting This powerful 1-hour FREE 3rd Thursday - a Operations Improvement webinar has 3 important objectives: 1. To demonstrate how a bottom-up version of ABCA can be used to better allocate support costs. With some commonly used value engineering tools, a new perspective of product cost can be developed. 2. To demonstrate how any standard cost accounting system can be made to calculate  more...
From GlobalCompliancePanel
Regulatory Complaint Handling MDRs Recalls - Webinar GlobalCompliancePanel Overview: Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Tuesday, July 3, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Statistical Procedures Needed for Compliance with the Guidance on Process Validation - Webinar By GlobalCompliancePanel Overview: This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft. Thursday, September 6, 2012  more...
The FDA Inspection Process From SOP to 483 - Webinar GlobalCompliancePanel Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight,  more...
Use of Risk Management during Process and Design Validation - GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Risk Assessment - Compliance Using Easy To Fill Out Documentation - Webinar By GlobalCompliancePanel Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. Wednesday, June 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Effective Corrective and Preventive Actions CAPA 10 Steps - Webinar By GlobalCompliancePanel Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Thursday, June 7, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Hazard Analysis vs FMECA Differences and Commonalities - Webinar GlobalCompliancePanel The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. Tuesday, May 22, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Bullet Proof 510k Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Tuesday, June 26, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
RAPS Approved Seminar on Risk Management in Medical Devices Industry at Mumbai Overview: The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management  more...
Lyophilization Process Development and Cycle Design with a Case Study - GlobalCompliancePanel Webinar Overview: This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive. Thursday, May 24, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles - Webin Overview: This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Tuesday, April 24, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Device Changes and the 510k - Webinar GlobalCompliancePanel Overview: The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. Wednesday, May 9, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...
Using Statistics to Determine Sample Size - Webinar GlobalCompliancePanel Overview: webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a  more...
Pharmaceutical Water System Use Monitoring Avoiding Problems by Doing It Right The Practicality of Real-Time Release - Webinar Overview: Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly  more...
Process Verification and Validation to Meet US FDA Requirements - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies.  more...
Use of Risk Management during Process and Design Validation - Webinar GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Use of Risk Management during Process and Design Validation - Webinar By GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Interfacing Design Verification Process Validation and Design Validation - Webinar GlobalCompliancePanel Overview: 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. Tuesday, March 13, 2012  more...
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which  more...
Essentials of Drug Safety and Pharmacovigilance - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical and biologic companies operating in the U. S. and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Thursday, April 19,  more...
Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel Overview: This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the  more...
How to Survive a QRM Audit - Webinar By GlobalCompliancePanel Overview: As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations. Such plans are being used as starting points for regulatory audits.  more...
How to Develop Monitor and Effectively Communicate your Risk Control Strategy - Webinar By GlobalCompliancePanel Overview: The intermediate level webinar assumes that attendees are conversant with the basic concepts of QRM. It addresses how to document the results of QRM in a RCS document, techniques to continuously monitor RCS performance and reporting of risk events and remediation to stakeholders. Subsequently, the focus shifts to the development of a process framework to manage risk through activities  more...
Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates  more...
Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompli This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...
New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities on-line e-learning cbt (computer based) This Webinar will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas  more...
Supply Chain Risk Management - Webinar By GlobalCompliancePanel Overview: For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and  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...
Lyophilization Process Development and Cycle Design with a Case Study - Webinar By GlobalCompliancePanel This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. Wednesday, January 11, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Risk Assessment - Compliance Using Easy To Fill Out Documentation - Webinar By GlobalCompliancePanel This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. Tuesday, February 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as  more...
Statistics in Quality Control - Critical decisions-Risks Basics - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...
Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  more...
New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...
Troubleshooting Ethylene Oxide EO Processes - Webinar By GlobalCompliancePanel Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...
Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...
New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the  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 This webinar provides an update on the status and evolution of HR audits. The HR auditing process is or should be an independent, objective, and systematic evaluation that 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  more...
Designing and Conducting Effective Structured Interviews - Webinar By TrainHR This webinar will cover the process of determining the right questions to predict success on the job, including questions to determine a cultural match to the organization, how to design a program with the advantages of structured interviews and elimination of the disadvantages some programs have  more...
Documenting Performance and Administrating Progressive Discipline - Webinar By TrainHR This webinar will cover discipline policies, standards of conduct, and the process of documenting performance and administrating progressive discipline, up to and including termination. It will also cover the objectives of discipline, the reasons for substandard performance, investigating circumstances and documenting discipline, the difference between counseling and coaching, when you can  more...
Job Evaluation Methods and Plans - Webinar By TrainHR Overview : In this program the speaker will review the purpose and types of Job Evaluation Plans, used to establish grade levels for a company's job classifications. Job Evaluation Plans such as Ranking, Paired Comparison, Whole Job Method, Hay Plan, Factor Comparison, GS Classification System, Single Factor, Limited Factor, and Competency based plans will be addressed. In addition, the factors  more...
Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...
Calculating Overtime Correctly - Webinar By TrainHR Overview : The information provided in this presentation covers proper procedures for calculating overtime and common pitfalls involved in the process. The importance of being thorough and correct when calculating regular rate of pay to avoid massive Department of Labor penalties is also highlighted as well as its importance in avoidance of suffering damages from civil law suits. Why you  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...
From OneSource Professional Training Solutions, Inc
ITIL v3 Service Operation Virtual Instructor Led instructor led trainingon-line e-learning cbt (computer based)courseware This five-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and  more...
From GlobalCompliancePanel
The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  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...
The 510k Process Risk Management - By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...
The 510k Process Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...
The 510k Process and Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...
The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...
Statistical Applications - Webinar By GlobalCompliancePanel instructor led training Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more.  more...
From ZaranTech.com
SAP FICO Online Competency Development Training program TRAINING DETAILS: Course Duration: 90 hours Training + Case Studies + 2 months Server access Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. a Access to the Training Blog Training Format: This course is delivered Online using Web and Audio Conferencing. Timing: Weekdays and Weekends after work  more...
JAVA J2EE JEE Professional Role Based Training from Zaran Tech TRAINING DETAILS: Course Duration: 80 hours Training + Actual project Case Studies + Assignments Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio  more...
SAP BOBJ with BW integration Online Competency Development Training program TRAINING DETAILS: Course Duration: 65 hours Training + Case Studies Training Materials: All attendees would receive a Assignment after each module, a Notes and study material for examples covered. Training Format: This course is delivered as a highly interactive session, with extensive live examples. This course is delivered in Online using Web and Audio Conferencing. Timing:  more...
Business Analyst Competency Development Program instructor led trainingon-line e-learning cbt (computer based)study at homecoursewaree-bookcomputer lab BUSINESS ANALYST Competency Development Program About Zarantech: Zaran Tech is a global IT training and consulting services company with one goal in mind a develop and deliver the highest quality consultants to our Clients and customer. As a consulting company, we help organizations to work smarter and grow faster. We consult with our clients to build effective organizations, innovate & grow,  more...
From GlobalCompliancePanel
A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  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...
Verification vs Validation in Regulated Industries - webinars by gcp Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.  more...
Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and 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  more...
Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".  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...
Risk Assessment - Compliance Using Easy To Fill Out Documentation BY GCP This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance  more...
CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...
Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing.  more...
Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin Failure Mode and Effects Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us  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...
Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such  more...
Introduction to Risk Management - Webinar by GlobalCompliancePanel on-line e-learning cbt (computer based) This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk  more...
Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department.  more...
Webinar on Specification Development - By GlobalCompliancePanel A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.  more...
Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their  more...
HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc Overview: In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and  more...
Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan  more...
DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and  more...
HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but  more...
Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as  more...
Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process  more...
The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is  more...
Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its  more...
Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification  more...
Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical,  more...
Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...
Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...
Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: 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 company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different  more...
Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel Overview: This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's  more...
FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441  more...
21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using  more...
Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel verview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems.  more...
Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel Overview: This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA  more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the  more...
Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated  more...
The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and  more...
How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production  more...
Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address  more...
Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel Overview: The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation  more...
Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how  more...
Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature  more...
Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel Overview: As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems)  more...
FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP Overview: The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack  more...
Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily.  more...
Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of  more...
Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel Overview: Laboratory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of  more...
The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...
Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...
Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written  more...
The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel Overview: This webinar will discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry  more...
A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing  more...
Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug  more...
Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel Overview: This program will provide the content for pharmaceutical manufacturing sites to establish sound quality management system procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for  more...
Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion  more...
Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory  more...
HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and  more...
HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not  more...
Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to  more...
Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel Overview: The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your  more...
Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.  more...
Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is  more...
Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for  more...
Developing the Risk Management Plan - Webinar By GlobalCompliancePanel Overview: This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product,  more...
FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel Overview: Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics  more...
Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel Overview: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM  more...
Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session  more...
Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the  more...
The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and  more...
Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the  more...
Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  more...
Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In  more...
Design Control for Medical Devices - Webinar By GlobalCompliancePanel Overview: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process 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  more...
Process Validation for Medical Devices - Webinar By GlobalCompliancePanel Overview: This course provides regulatory/ quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of  more...
How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel Overview: Virtually all field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya  more...
Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for  more...
Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as  more...
Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...
Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  more...
FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed  more...
Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and  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 Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools  more...
Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call  more...
Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  more...
Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...
Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...
Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel Overview: This three hour overview of investment risk will provide the fundamentals to market, portfolio, and credit risk management that all investors, and those in financial services need to comprehend. Regardless of job titles, investment risk management is a shared responsibility by a wide range of managers. Compared to accounting, risk is an immature discipline with a variety of risk  more...
Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel Overview: This webinar 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. The seminar begins with Excel methods to help ensure the spreadsheet produces the results  more...
Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product  more...
Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals  more...
Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a  more...
Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of  more...
International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel Overview: Where business is concerned the world is becoming a smaller place. Trade boundaries are disappearing, and many companies have subsidiaries around the world. Multi-national corporations needed a simpler way to put together their consolidated financial statements. Already Australia, most of Europe, and many other countries have adopted International Financial Reporting Standards.  more...
Practical Laboratory Statistics - Webinar by GlobalCompliancePanel Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test  more...
From RightPro Inc
SAP Profitability Analysis COPA instructor led trainingon-line e-learning cbt (computer based)study at homee-bookbooktrain the trainercomputer lab SAP Expert Training on Controlling and Profitability Analysis Modules ERP -- SAP Area -- Finance Specialization -- Controlling and Costing Course -- CO-PA Number of Hours -- 30 Hours Please contact for Demo Class sriman@ficoanalyst. com Expert Advice, Blueprint Discussion, Configuration, Process Executuion, Hands on Training, Testing Templates, Cutover  more...
From GlobalCompliancePanel
Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing  more...
21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...
Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel Overview: Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical  more...
Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...
Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel Overview: This presentation will assist 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 *  more...
Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel Overview: The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize  more...
Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement  more...
Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary  more...
Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical  more...
Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel Overview: Both the U. S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected  more...
Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...
Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel Overview: This presentation will answer some of the frequent questions of new trainers 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  more...
Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the  more...
Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel Overview: Preparation and organization are the keys to a successful audit. This session will allow your team to anticipate the auditors needs and result in the facility's ability to achieve the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits.  more...
Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...
Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA's concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates that CAPA systems  more...
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of  more...
Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  more...
Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom Overview: If you handle any electronic patient information, don't miss this teleconference on compliance with 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,  more...
Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes,  more...
Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still  more...
Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...
Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the  more...
Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel Overview: With today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative  more...
Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows  more...
Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...
Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles  more...
How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  more...
Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the  more...
New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel Overview: New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/ or finalized to meet the privacy and security mandates within the HITECH Act in the 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  more...
Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel  more...
Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The  more...
Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that  more...
Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign  more...
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