This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent product / equipment / process V&V requirements and execution. And now the FDA is taking an even tougher stance.
Why do companies need robust V&V?
What are the “must have” elements from the cGMPs and best practices?
How do you define and use IQ, OQ, PQ, or their equivalents?
How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor in and assist to allocating limited company resources?
How can these be integrated into the company’s quality management system?
Areas Covered in the Session :
- IQ, OQ, and PQ, major components of robust Verification and Validation V&V programs – Regulatory requirements
- The Master Validation Plan(s)
- Individual V&V Plans and their execution
- Product Verification and Validation
- Process and Equipment V&V; including software
QMS V&V and 21 CFR Part 11
- When / How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents
- The 11 Elements of the FDA’s Software VT&V “Model”
- Incorporating the Hazard Analysis / Risk Management tools of ISO 14971 or ICH Q9
- How to Avoid recent compliance problems
Who Should Attend:
This webinar will provide valuable assistance to all regulated companies that need to review and modify their company’s planning and execution of verification and validation, based on a proper understanding of the roles of IQ, OQ, and PQ, or equivalent terminology. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
- Senior management
- Middle management
- Research & Development
- QA / RA
- cGMP instructors
- All personnel involved in verification and/or validation planning, execution and documentation.