FDA Perspective On QbD for Analytical Methods | AIChE

FDA Perspective On QbD for Analytical Methods

Type

Conference Presentation

Conference Type

AIChE Annual Meeting

Presentation Date

October 17, 2011

Duration

30 minutes

Skill Level

Intermediate

PDHs

0.50

QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and development. However, many of the QbD approaches and tools are applicable to analytical methods as well. The linkage between QbD and analytical method development and validation needs further development. Inclusion of enhanced pharmaceutical development information, including analytical method development and validation studies, in the submissions will provide the applicants the opportunity for flexible regulatory approaches, recognizing however, the degree of regulatory flexibility is predicated on the level of demonstrated product, analytical method and manufacturing process understanding. A summary of the progress made to date and the continued challenges facing the industry and FDA will be presented.

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 Pro Members $15.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
AIChE Explorer Members $25.00
Non-Members $25.00