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Webinar On "Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process"

Event Details

Webinar On "Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process"

Time: July 26, 2018 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: https://www.compliancetrainin…
Phone: 1-844-216-5230
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Jul 14

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Event Description

Description :
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.
Objective :
The objective of this webinar is that attendees will better understand contemporary expectations for process validation and how these support the quality system approach to compliance.
Areas Covered in the Session :
  • 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 life cycle to test method validation.
Who Will Benefit:
  • 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
About Speaker:
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 he has managed Analytical Research, Quality Control and Quality Assurance functions.

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