Limited Time Offer

Claim a 25% discount on your eLearning and instructor-led courses purchases with code EDU25OFF.

Offer is valid from October 1-31. Exclusions may apply.

CMC Reviewer Expectations for ANDAs Using QbD Approaches

  • Type:
    Conference Presentation
  • Checkout

    Checkout

    Do you already own this?

    Pricing


    Individuals

    AIChE Member Credits 0.5
    AIChE Members $15.00
    AIChE Graduate Student Members Free
    AIChE Undergraduate Student Members Free
    Non-Members $25.00
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    October 18, 2011
  • Duration:
    30 minutes
  • Skill Level:
    Intermediate
  • PDHs:
    0.50

Share This Post:

There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA. There are particular challenges for generic drug manufacturers with respect to using QbD approaches, especially with more complex dosage forms, such as modified release (MR) products. In an effort to increase transparency with the generic industry and the pharmaceutical industry at large, this presentation will provide insight into CMC reviewer expectations when evaluating pharmaceutical development studies, the applicant’s process and product understanding, use of risk assessment tools, and proposed control strategies.
Presenter(s): 
Once the content has been viewed and you have attested to it, you will be able to download and print a certificate for PDH credits. If you have already viewed this content, please click here to login.

Checkout

Checkout

Do you already own this?

Pricing


Individuals

AIChE Member Credits 0.5
AIChE Members $15.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $25.00
Language: