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?
While focused on CGMP compliance, it is suitable for ISO 13485 and ISO 9001 (international / global) compliance as well.
Areas to be Covered:
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 will Benefit:
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:
Research & Development
QA / RA
All personnel involved in verification and/or validation planning, execution and documentation.