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Process Validation
Process Validation
Process Validation

This webinar provides a first time public review and understanding on the new draft Guidance for Industry – Process Validation as presented by Grace McNally, (US FDA). Grace spoke about the General Principles and Practices of the Guidance by highlighting major concepts and potential industry impact. Paul D’Eramo, Executive Director, Johnson & Johnson, hosted the Question and Answer session which gave the attendee’s the chance to submit their questions and have them answered by Grace McNally directly. At the conclusion of this session, participants will be able to:

  • Highlight the most important concepts in the draft guidance
  • Better interpret the guidance intent
  • Gain insight into how the guidance may impact your company

  • Approximate Course Duration: 90 minutes (this is a self-paced course)
    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.
    ISPE CEUs: .15 ISPE CEUs will be awarded upon successful completion of grading requirements

    Speaker Biography
    Grace McNally is a Senior Policy Advisor in CDER’s Office of Compliance, Office of Manufacturing and Product Quality. Previously, she served as a Compliance Officer handling domestic CGMP cases. She has participated in developing guidance for industry in the areas of process validation, combination products, contract manufacturing, participated in revisions of the CGMP regulation, as well as developing training for FDA and industry. Grace began her FDA career as a field investigator, first in Philadelphia District and then later in Denver District where she specialized in pharmaceutical and medical devices inspections. She graduated with a B.S. in physics from Boston College, Chestnut Hill, Massachusetts.

    Discounted member price: 49.00
    Your price: 149.00
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    This webinar provides a first time public review and understanding on the new draft Guidance for Industry – Process Validation as presented by Grace McNally, (US FDA). Grace spoke about the General Principles and Practices of the Guidance by highlighting major concepts and potential industry impact. Paul D’Eramo, Executive Director, Johnson & Johnson, hosted the Question and Answer session which gave the attendee’s the chance to submit their questions and have them answered by Grace McNally directly.

    Member Price: $ 49.00 / € 40.00
    Non Member Price: $ 149.00 / € 110.00
    Item #: WEBPROCVALUS

    Publishing Date: 01/09


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