HUM-MOLGEN events: IBC's Effective Audit Strategies for Global API Manufacturers

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IBC's Effective Audit Strategies for Global API Manufacturers

June 06, 2003

IBC Life Sciences, Washington, D.C.
August 14-15, 2003

This course begins with the current trends in the pharmaceutical and biotech industry, followed by how to enter into a quality agreement with a vendor and the responsibility of the sponsor with regard to regulatory compliance requirements. It will also cover how to audit a vendor using the recent API ICH Q7A guidelines and its requirements in the manufacture and control of APIs. The audit strategy and conduct will include both biologic and chemical API manufacturers, what to include in the audit agenda, how to interact with foreign API manufacturers, and how to prepare vendors for an initial regulatory inspection that is triggered by a marketing application.

Organized by:

IBC Life Sciences

Invited Speakers:

Course Instructor:
K.A. Ajit-Simh, Shiba Associates

Deadline for Abstracts:

Registration:

Phone: (508) 616-5550 x1004 Fax: (508) 616-5522 E-mail: reg@ibcusa.com Online: www.LifeSciencesInfo.com/2919

E-mail:

reg@ibcusa.com

Posted by:

James G. Prudhomme

Host: