Process Validation – The Lifecycle Concept

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, May 10, 2016
90 minutes
Product Description

FDA Guidance on Process Validation and How it Relates to ICH Q10, ICH Q9, ICH Q8


ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle. Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle.

The Europeans followed with a similar guidance for process validation including the lifecycle concept. This has now been incorporated into the revised Annex 15: Qualification and Validation of the EU GMPs. Worldwide, the pharmaceutical community is approaching process validation as a process control tool that is applied to pharmaceutical production processes throughout the life of the process and the product. It is now a challenge for the process validation team to integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.

In this session, expert speaker Jerry Lanese Ph.D., will discuss on the FDA guidance on process validation and how the expectations found in this guidance relates to ICH Q10, ICH Q9 and ICH Q8. It will help you better understand the contemporary expectations for process validation and how these support the quality system approach to compliance.

You’ll also get a copy of FDA guidance: Guidance for Industry - Process Validation: General Principles and Practices.

Session Highlights:

  • The FDA Guidance on process validation and how the expectations found in this guidance correlate to:
    • ICH Q10; The Pharmaceutical Quality System
    • ICH Q9; Quality Risk management
    • ICH Q8; Pharmaceutical Development
  • The three stages of process validation and what must be done during each stage.
    • Stage 1; Process Design
    • Stage 2; Process Qualification
    • Stage 3; Continued Process Verification
  • The extension of the concept of process lifecycle to test method validation.

Session Agenda:

  • The FDA Process Validation Guidance
  • EU Annex 15
  • ICH Q8: Pharmaceutical Development
  • ICH Q9; Quality Risk Management
  • ICH Q10; The Quality System

Who should attend?

  • Management at all levels who are responsible for process development and validation
  • Personnel who are responsible for
    • Product development
    • Process transfer
    • Process validation
    • Demonstration that a process continues to perform in a state of control,
  • QA, personnel who are responsible for the review and approval of process validation protocols and reports
  • Validation specialists

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
More Events By The Speaker

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