Process Verification and Validation Planning and Execution

John E. Lincoln

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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.

Course "Process Verification and Validation Planning and Execution" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC re-certification upon full completion.

Course Objective

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 planning. Why do companies need a Master Validation Plan? 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 quality management system.
This webinar will help you develop or refine the company Master Validation Plan to meet FDA / cGMP expectations. It will address the FDA's newer and tougher regulatory stance.
Attendees will learn how to incorporate key principles of the FDA's new Process Validation guidance, to include targeted risk-based V&V planning. We will discuss how you can add the new process validation principles, initiate a Master Validation Plan; evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management; focus on the development of meaningful product, process, facility, and/or QMS validations.
We will also discuss the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or the ASTM E2500 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.

Course Outline

  • Process Validation -- New regulatory expectations.
  • Adjusting the Master Validation Plan.
  • Product, Process / Equipment V&V.
  • When and How to Use DQ, IQ, OQ, PQ.
  • Using the Risk Management tools of ISO 14971 and ICH Q9.
  • The 11 Elements of the Software VT&V "Model".
  • Avoid recent "horror stories" and multimillion dollar fines.

Target Audience

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

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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. John is a graduate of UCLA

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