Verification and Validation

Verification recently ranked in the top 5 reasons for Warning Letters from the FDA!

Verification and Validation appear frequently in ISO 13485, MDSAP, 21 CFR 820, 21 CFR 211, ISO 14971, US Pharmocopeia, and many such documents. Many people use the confuse between the two terms, and use them interchangeably. These terms are applied for myriad settings and purposes; to a process step / activity, a process, design, a test method, tool, production equipment, product, AND to changes in any of these. Thus, it is easy to see why the citations are high.

A clear understanding of the meaning / intent of each “V” is therefore essential. Come explore which one makes sense, and under what circumstances. Delve into the benefits and down sides of attempting to do one or the other – including the financial and risk based impact.

Areas Covered in the Session :

• What is verification
• What is validation
• When to use which
• How you can plan and conduct studies to support V&V
• Writing V&V Reports, and what to include in such reports
• Impact (risk based, and financial) of doing one, or the other
• Bring your questions, and take away some answers

Who Should Attend:

• Regulatory Affairs Departments
• Quality Departments
• Compliance Departments
• Research and Development Departments
• Engineering Departments
• Manufacturing Departments
• Laboratory Professionals
• Auditors

Course Director: RAI CHOWDHARY

Rai Chowdhary brings over 30 years of business and technical expertise from diverse industries to bear during his workshops. He has implemented Risk Management in several organizations, and coached thousands of participants in the approach. He has worked with / for world leaders such as Applied Materials, Dell, DuPont, Frito-Lay, Tokyo Electron, Samsung, Intermedics Orthopedics / Sulzermedica, Abbott Spine, Amedica, Edwards Life Sciences, Evenflo, Reckitt Benckiser, Ultradent, Siemens, GE, Philips, and more. Rai holds certifications from ASQ as: Quality Auditor, Quality Engineer, Quality Manager / Operations Excellence, and Six Sigma. He has conducted several workshops (including Lead Auditor training) on a vast range of topics such as: ISO 9001, 13485, 14971, IEC 62366, AS 9100, 21 CFR 820, MDDEV, Risk Management, Lean, Six Sigma, etc. He is an award winning presenter, and top rated workshop leader. His book on The Ten Mistakes of Risk Management was first published in 2007; an updated version is expected soon.