Robust Verification and Validation

Scheduled On : Wednesday, October 16, 2013 at 10 AM PDT | 1 PM EDT
Duration : 90 Minutes

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Description :

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.

Why do companies need robust V&V?
What are the "must have" elements from  the cGMPs?
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 :

• Robust Verification and Validation -- Recent Regulatory requirements.
• The Master Validation Plan(s).
• Individual Verification and Validation Plans and their execution.
• Product Verfication & Validation.
• Process and Equipment Verfication & Validation, including Software.
• 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.

 

Who Will Benefit:

 

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. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The professionals who will benefit include all:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• cGMP instructors

And all personnel involved in verification and/or validation planning, execution and documentation.

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.