Recent FDA Warning Letters and high-profile product recalls have revealed significant cGMP deficiencies across the life science industry. One of the most common gaps is the absence of a robust, risk-based company-wide Validation and Verification (V&V) strategy.
This course provides a detailed, practical approach to developing an effective Master Validation Plan (MVP) that aligns with FDA and EU (Annex 15) expectations. You will learn how to evaluate your plan against ISO 14971 risk management principles to ensure all validation activities are risk-based, traceable, and audit-ready.
This course provides a detailed, practical approach to developing an effective Master Validation Plan (MVP) that aligns with FDA and EU (Annex 15) expectations. You will learn how to evaluate your plan against ISO 14971 risk management principles to ensure all validation activities are risk-based, traceable, and audit-ready.
Key topics include:
- How to design and structure a Master Validation Plan that meets FDA, EMA, and ISO standards.
- Using Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) - or their ASTM E2500 equivalents - efficiently, even with limited resources (time, budget, personnel).
- Building a practical V&V matrix that connects product, process, equipment, and software validation, ensuring no regulatory requirement is overlooked.
- Understanding the FDA definition of “risk-based validation” and how to document it effectively in your V&V test reports.
- Integrating QMS, cGMP, and 21 CFR Part 11 requirements to support a compliant, inspection-ready validation system.
- Identifying the supporting systems and documentation necessary for sustainable validation compliance.
Agenda
1: VMP, The Unwritten Requirements ~75 mins 70 slides- Verification and Validation - defined
- VMP Planning and the VMP
- Individual Validation Plan / Test Report
- Requirements
- DQ, IQ, OQ, PQs: Test Cases, Examples
- Determine the number of PQs - no “rule of threes”
- Software V&V documentation
- Break/Q&A 10 mins
- Mandatory ISO 14971 and ICH Q9
- What Risk Is, and Isn’t
- The Risk Management File
- Narrative; Hazards List, FTA, D-, P-, and U-FMECAs
- Used “as needed”
- IEC 62366-1, -2
- A Human Factors / Use Engineering “Process”
- The 9 Stages
- The UE File
- Q&A ~10 mins(and Summation)
- End
Course Provider
John E Lincoln,
