Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
Product ID : JOLI-0001
Level : Intermediate
Duration : 90 Minutes
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 35 years experience in U.S. FDA-regulated industries, 21 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 including 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). 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 periodically writes for the Journal of Validation Technology. John is a graduate of UCLA.
How can companies address the U.S. FDA’s tougher stance and product, process, and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, process, equipment, QMS, software V&V. What are the key components in understandable language? How is it run? What are the "must-have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's QMS?
- Regulatory “Hot Buttons”
- V&V Background and Terms Defined
- The MVP / VMP
- Device / Product V&V
- Drug / Process V&V
- Software/firmware V&V
- QMS V&V
- Applicable guidance documents
- Suggested “Models”
- Data Sources / Metrics
Who Should Attend
- Senior management
- Middle management
- SW programming/engineering
ISO 9001 and 13485 affected industries.
FDA-Regulated Industries: Drugs, Devices, Biologics, Combo Products, Dietary Supplements
Why Should You Attend
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big-name device and pharma companies. One major failing is the lack of sufficient or targeted risk-based Verification and Validation planning and execution. Another is confusion over terminology. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? What are the "must-have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's QMS? How to meet the similar V&V requirements of ISO 13485. Eliminate the confusion over V&V terminology. Develop a repeatable and CGMP-compliant V&V system.