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Implementation of QbD: An FDA Perspective
Implementation of QbD: An FDA Perspective
Implementation of QbD: An FDA Perspective

This presentation provides a background of current FDA and ICH initiatives and guidance for product quality. It presents activities and experience in the Office of New Drug Quality Assessment (ONDQA) to support Quality by Design (QbD) approaches. Finally, considerations for QbD submissions are provided. At the conclusion of this session, participants will be able to:

  • Have an understanding for FDA and ICH initiatives and guidances for quality
  • Learn about ONDQA activities for supporting QbD
  • Know some considerations for QbD submissions

  • Approximate Course Duration: 45 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: .08 ISPE CEUs will be awarded upon successful completion of grading requirements

    Speaker Biography
    Dr. Christine Moore is the Deputy Director for Science and Policy and currently Acting Director of FDA's Office of New Drug Quality Assessment. She started at the agency in 2004 as the Branch Chief of the newly created Manufacturing Science group. Christine has been actively involved in FDA's Quality by Design initiatives and was a member of the expert working group for ICH Q8(R). Prior to joining the FDA, she worked for 10 years in API process development and scale-up at Pfizer and Searle/Pharmacia. Her background is in chemical and biochemical engineering, with degrees from Northwestern University and Massachusetts Institute of Technology.

    Discounted member price: 49.00
    Your price: 149.00
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    This presentation provides a background of current FDA and ICH initiatives and guidance for product quality. It presents activities and experience in the Office of New Drug Quality Assessment (ONDQA) to support Quality by Design (QbD) approaches. Finally, considerations for QbD submissions are provided.

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


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