Change Location × Washington DC

    Recent Locations

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


      • Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process Photo #1
      1 of 1
      July 26, 2018

      Thursday   1:00 PM - 2:30 PM

      This is an Online Webinar
      Bethesda, Maryland 20817

      Map
      Performers:
      • No Performers Listed
      EVENT DETAILS
      Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process

         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.



      Event URL: https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MP00102



       



      Organizer: Compliance Training Panel



      Website:  www.compliancetrainingpanel.com/Webinar/Live



      Email: support@compliancetrainingpanel.com



      Phone: 844-216-5230

      Cost: 239.00

      Categories: Conferences & Tradeshows | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
      COMMENTS ABOUT Process Validation – Integrating ICH Q8, Q9 and Q10 into the Process Validation Process