Master Validation Plan - The Unwritten Requirements is a webinar that covers topics such as:
- The Master Validation Plan and its structure
- Verification or Validation - Recent regulatory expectations
- Process / Equipment / Facility Validation including FDA`s recent guidance
- Product Validation - how it differs from process / equipment V&V
- How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- Incorporating 21 CFR Part 11 requirements
- The 11 key documents for software validation
- Approximately two 10 minute breaks during the webinar, with Q&A
- Suggested "test case" formats
Master Validation Plan - The Unwritten Requirements brings together:
- Supplements
- Senior Management in Drugs, Devices, Biologics, Dietary
- RA
- QA
- Engineering
- R&D
- Operations
- Production
- Consultants,Others tasked with Product, Process, Software Validation Responsibilities
