IBC Life Sciences, The Hilton at Dedham Place, Dedham, MA
October 20-21, 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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