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.
Course Director: JOHN E. LINCOLN
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.