Which CSV Model Should you Use: V-model, GAMP 5 or ASTM E2500?

This training on computer system validation models will explain the distinctions and similarities between three CSV models - V-model, GAMP 5 and ASTM E2500 - and show how you can apply the most appropriate model for your application and significantly reduce your regulatory risk.

Why Should You Attend:

This webinar will help the attendees learn how to take out the mystery of selecting a validation model that is appropriate for their application, thereby reducing risk exposure to audit failure.In this webinar, find out the answer to why these validation models evolved over the years and what specific needs each one of them addresses. Attendees will learn how to develop skills to analyze, select and document the rationale for the choice of validation model. Expand your industry knowledge by attending this webinar to familiarize yourself and expand your CSV knowledge in the following areas:

• What is an enhanced collapsed CSV architecture and which CSV model reflects it the best
• When to use and when not to use the collapsed architecture
• What are CSV categories and what criteria to use to categorize the system
• What you need to do to acquire the necessary skills to develop good documentation
• What are the most common CSV violations and how do auditors go about looking for these violations
• What are “tag along audits” and how to shield yourself against such audits
• CSV inspection trends

At the conclusion of this webinar, you will be able to determine whether your company’s CSV strategy is vulnerable to the most common violations and what you need to do to plug these vulnerabilities.

Areas Covered in the Webinar:

• Quality attributes of CSV documentation with examples
• The classical V-model, GAMP V and ASTM model explained
• Distinctions and similarities between these three models
• What are auditors trained to look for during CSV audits
• What are “tag along” audits and the necessary steps you need to take to shield yourself
• Examples of some recent 483s and WL

Who will Benefit:

This webinar will provide valuable assistance to all personnel in FDA regulated companies

• Healthcare providers
• Regulatory, QA/QC personnel
• Engineering, Manufacturing and Manufacturing Science
• IT and Software Quality Assurance personnel
• Project managers and Validation consultants

Instructor Profile:

Chinmoy Roy, BSEE, MSCS is an independent engineering and compliance consultant with over 37 years of experience. He is a practicing professional advising companies worlwide. He is an acclaimed trainer and is considered an industry expert in manufacturing automation, CSV, CFR 21 Part 11, QRM, Internal and External audits, and QA of computer systems. His team pioneered the successful implementation and validation of a CFR 21 Part 11 compliant system at a paperless bulk manufacturing control system. This highly complex system was a precursor to FDA’s Part 11 Scope and Application Guidance document in 2003