Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
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?
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 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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management
• Middle management
• QA/RA
• Operations
• Production
• Engineering
• SW programming/engineering
• Marketing
• Consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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