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Validity : 20th Apr'24 to 30th Apr'24
Master Validation Planning to meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 requirements
- Verification and Validation — Recent Regulatory requirements
- The Master Validation Plan(s)
- Product Verification & Validation
- Process and Equipment Verification & Validation
- QMS V&V and 21 CFR Part 11
- When and How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents
- The 11 Elements of the FDA’s Software VT&V “Model”
- Incorporate the Hazard Analysis / Risk Management tools of ISO 14971 and ICH Q9
- Avoid recent compliance problems
Overview of the webinar
This 90-minute in-depth webinar discusses the 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 V&V planning.
And now, the FDA is taking an even tougher stance.
Who should attend?
This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). Its principles apply to personnel/companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include:
- Senior management
- Middle management
- R&D
- Engineering
- Software
- QA / RA
- Manufacturing
- Operators
- Consultants
- cGMP Instructors
- All personnel involved in verification and/or validation planning, execution and documentation
Why should you attend?
- Why do companies need a Master Validation Plan?
- What are the “must have” elements from the cGMPs?
- How do ISO 14971 and ICH Q9 for hazard analysis and product risk management factor assist in allocating limited company resources?
- How can these be integrated into the company’s Quality Management System?
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished 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.