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EMA Requirements

Dissolution Instrument Qualification to Meet Requirements and Minimize Product OOS Dissolution Results

Submitted by Anonymous on Mon, 01/30/2012 - 03:05
02/28/2012 10:00 am
02/28/2012 12:00 pm
America/Chicago

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

Why Should You Attend:

This interactive course is designed to provide the participant with a knowledge of the requirements for dissolution instrument qualification, an area which has been changing rapidly over the last few years. Both the use of USP Performance Verification Tablets and mechanical approaches will be discussed, as well as the requirements presented in the USP and in a recent FDA Guidance. Pitfalls in the performance of the tests as well as instrument issues which are not addressed by the Qualification procedures will be addressed. Finally, some of the practical suggestions that can minimize both PVT and product failures will be presented. There will be ample opportunity for participant questions.

Webinar Presenters: 
Greg Martin
Webinar URL: 
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=7019...
  • Calendar
Tags:
  • Dissolution Instrument Qualification
  • education
  • EMA Requirements
  • FDA requirements
  • FIP Position Paper
  • Mechanical Qualification
  • USP 1058
  • USP Performance Verification Tablets
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