Validation Master Planning - The Unstated Requirements

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is 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? 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?

This webinar training will review a company's Master Validation Plan or Validation Master Plan for major cGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Validation Master Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product and process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. Our matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are considered as well.

Areas Covered in the Webinar:

• Verification or Validation - Recent Regulatory Expectations
• The Validation Master Plan
• Product V&V versus Process / Equipment V&V
• When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
• Using the Risk Management Tools of ISO 14971 and ICH Q9
• The 11 Elements of the Software VT&V Model
• Avoid Recent Compliance Problems

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on medical devices, its principles apply to personnel / companies in the pharmaceutical, diagnostic, and biologics fields. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality assurance
• Production
• Engineering including software
• All personnel involved in verification and/or validation planning, execution and documentation

Instructor Profile:

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. He 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. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs to the level of director and VP (R&D).

In addition, Mr. Lincoln 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 writes a recurring column for the Journal of Validation Technology. Mr. Lincoln is a graduate of UCLA.

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