FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered.
Areas Covered in the Session: - Verification or Validation - Recent regulatory expectations
- The Master Validation Plan
- Product Validation - how it differs from process / equipment V&V
- Process / Equipment / Facility Validation
- When and How to use DQ, IQ, OQ, PQ
- How to use your Risk Management Tools (per ISO 14971)
- The 11 "must have" elements of software validation
- 21 CFR Part 11 issues
- Possible "test case" formats.
Who Will Benefit: - Senior management, project leaders
- Regulatory Affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing company-wide V&V planning, using a risk-justified approach
- CAPA and P&PC personnel desiring to verify proposed solutions and minimize post-production / life cycle and other costly problems.
