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 company-wide 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, or their equivalents per ASTM E2500, 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 also be considered.
Why You Should Attend: Verification and validation requirements have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased.
Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, are not documented in a top tier Master Validation Plan, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.
Areas Covered in the Session:
- Verification or Validation - Recent regulatory expectations
- The Master Validation Plan and its structure
- Product Validation - how it differs from process / equipment V&V
- Process / Equipment / Facility Validation - including FDA's recent guidance
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
- The 11 key documents for software validation
- Incorporating 21 CFR Part 11 requirements
- Suggested 'test case' formats
John E. Lincoln,