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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"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"

Both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning

Description

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.

Areas Covered

  • 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.

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

John E Lincoln

Principal, J. E. Lincoln and Associates LLC

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).

In addition, he 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 is a graduate of UCLA.

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