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.
- 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
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Research and Development Departments
- Engineering Departments
- Manufacturing Departments
- Laboratory Professionals