Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
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 Attend
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big-name device and pharma companies. One major failing is 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.