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| HUM-MOLGEN -> Events -> Courses and Workshops | ||||||||||||||||
| Professional Development Course - IBC's Effective Audit Strategies for Global API Manufacturers | ||||||||||||||||
| March 27, 2003 | ||||||||||||||||
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-, San Diego Courtyard - Kearny Mesa, San Diego, CA May 8-9, 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. You will learn how different API vendors apply cGMPs, gain an understanding of the requirements for a quality agreement, get a thorough understanding on the interpretation and application of the ICH Q7A guideline, understand the differences between a biologic and chemical API, and learn effective communication with API manufacturers that can successfully bring them into compliance. |
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| Organized by: | IBC Life Sciences | |||||||||||||||
| Invited Speakers: | Course Instructor: K.A. Ajit-Simh, Shiba Associates |
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| Deadline for Abstracts: | - | |||||||||||||||
| Registration: | Phone (508) 616-5550 x1004 Fax (508) 616-5522 On-line www.LifeSciencesInfo.com/2919 Mail IBC USA Conferences, Inc. One Research Drive, Suite 400A P.O. Box 5195 Westborough, MA 01581-5195 | |||||||||||||||
| E-mail: | reg@ibcusa.com | |||||||||||||||
| Posted by: | James G. Prudhomme | |||||||||||||||
| Host: | host-65-124-112-226.ibcusa.com | |||||||||||||||
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