Process Verification and Validation Planning and Execution

Instructor: John E Lincoln
Product ID: 701662
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

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 process V&V planning / execution. Pharma companies must consider key elements of the FDA Process Validation Guidance Document; other medical products can use the same principles. Incorporate the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product / process risk management. Then integrate all as process validation essentials and incorporate into a company's quality management system.

This webinar will review a company's process verification and validation system for major cGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. Attendees will learn how the FDA's recent process validation guidance for pharma can assist all regulated industries meet regulatory requirements. It will discuss how one can start with a Master Validation Plan, evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations.

It will also discuss 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. The speaker will present a matrix that 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 will also be discussed briefly.

Areas Covered in the Webinar:

  • Verification or Validation -- Recent regulatory expectations
  • FDA's Current Process Validation Guidance
  • Key Process / Equipment V&V Considerations
  • 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 Process Validation Planning and Execution / Documentation. While this information is focused on Pharmaceutical and Medical Devices, its principles apply to personnel / companies in the Diagnostic, Combination, and Biologics fields as well. 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 32 years experience in U.S. FDA-regulated industries, 18 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. 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 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. John is a graduate of UCLA.

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Product Reviews Write review

From new perspective of FDA's enforcement and Process Validation guidance to Key areas on Validation and Life cycles this seminar provides a very good perspective on how to direct our companies efforts and focus resources.
- Anonymous

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