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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This webinar provides a first time public review and understanding on the new draft Guidance for Industry – Process Validation as presented by Grace McNally, (US FDA).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  • Highlight the most important concepts in the draft guidance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

  • 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
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    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

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00

    Publishing Date: 01/09

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