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Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements


Location: California, USA
From: 2021/07/07 10:30
To: 2021/07/07 11:30
Posted by: WCS Compliance

About this event

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Overview

Webinar for a discussion of the webinar how to review a company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Major industry failings are lack of sufficient or targeted risk-based V&V planning. Use the VMP and Product Risk Management Files to develop meaningful product and process validations.

Address "worst case allowables". Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources. The models presented simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. V&V of a company's QMS and 21 CFR Part 11 are considered.

Why Should You Attend

FDA Warning Letters and high-profile recalls indicate major cGMP deficiencies in device and pharma companies on both sides of the Atlantic. One major failing is lack of sufficient or targeted risk-based V&V planning. And confusion over what the terms "risk-based", V & V,and other terms really mean. A review of Internet forums shows confusion as to what is risk and what is V&V planning. What is the VMP and the individual V&V plan and their formats and roles. What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated? Mandatory risk for Software / firmware V&V.

Webinar Takeaways
  • Verification or Validation -- Current regulatory expectations.
  • The Master Validation Plan and the Individual V&V Plan.
  • Product V&V versus Process / Equipment V&V versus QMS 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"
  • Key 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, and other fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering, indluding Software
  • All personnel involved in verification and/or validation planning, execution and documentation.

John E. Lincoln

Medical Devices / Regulatory Consultant; also pharma and dietary supplements

Saint George, Utah

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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).



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