GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP® 5.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.  It also ensures that you do not go beyond what is required for a specific classification of system so as to be cost-effective.

Course Objectives:

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations.  A full understanding of how to categorize such a system is key to ensuring this process will be adequate.

There is an enormous body of documentation and information available on the subject that can be overwhelming.  This course will provide a condensed overview of the most critical methods, techniques and tools available for interpreting GAMP® 5 and related guidelines for validation.

In this session we will talk about:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP)(Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy
• System Risk Assessment
• GAMP® 5 “V” Model

Course Outline:

This webinar will cover the following key areas:

• Gain an understanding of GAMP® 5  computer system classifications
• Develop the ability to apply GAMP® 5  in classifying computer systems in your organization
• Understand the level of computer system validation required, based on the classification as determined using GAMP® 5
• Discuss the best practices necessary to ensure all systems are classified properly and validated appropriately
• Learn how to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP® 5
• Understand how to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validated
• Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
• Understand the level of training required for the various GAMP® 5  computer system classifications, and the skills and expertise necessary to make the classification determination

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Information Technology (IT) Analysts / Developers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Quality Managers, Chemists and Microbiologists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit www.ispe.org