Proposed Revision to FDA Guideline on the Preparation of Investigational Products (Human and Animal)

Recorded Date: March 2004
Course Type: Recorded On-line Seminar

Speaker:
Nancy Maiorino, Asst. Director, Clinical Packaging, Perdue Pharma

This Recorded On-line Seminar reviews a brief history of the development of the current guideline as well as an overview of the sections covered in the current guideline, and a review of all sections in the proposed guideline. The proposed guideline provides additional guidance to companies and individuals who are involved in the preparation of IND products and contains supplemental information intended to clarify compliance with cGMPs.

At the end of this Recorded On-line Seminar, participants will be able to define the history of the guideline, explain why the guideline was developed and discuss the developments and evolution of practice in the industry that lead to the proposed revisions to the guideline.

Who Should Attend
This Recorded On-line Seminar benefits pharmaceutical professionals involved in the preparation of investigational products.

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CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

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