Overview:
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.
What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation. The QMS / CGMP 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
- Approximately two 10 minute breaks during the webinar, with Q&A
Who Will Benefit:
- Senior Management in Drugs, Devices, Biologics, Dietary
- Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants,Others tasked with Product, Process, Software Validation Responsibilities