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

Thursday July 26th 2018

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   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.

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 :

   1: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 

   2: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 

   3:The extension of the concept of process lifecycle to test method validation.

   Attendees will better understand contemporary expectations for process validation and how these support the quality system approach to compliance.

Who Will Benefit:

   1:Management at all levels who are responsible for process development and validation

   2:Personnel who are responsible for 

  •          Product development
  •          Process transfer
  •          Process validation
  •          Demonstration that a process continues to perform in a state of control 

   3:QA, personnel who are responsible for the review and approval of process validation protocols and reports

   4:Validation specialists.

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.

   In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.

   Dr. Lanese focuses on training. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.

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Organizer: Compliance Training Panel



Phone: 844-216-5230

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Starts: Thursday, July 26th 2018 at 1:00pm
Ends: Thursday, July 26th 2018 at 2:30pm

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Timezone: US/Eastern
Bookings close: July 26th 2018


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