The Center for Professional Advancement, Amsterdam
3-4 December 2007
Who Should Attend:
This comprehensive course has been designed for individuals whose responsibilities require an understanding of the quality and regulatory aspects of Active Pharmaceutical Ingredient (API) production for both commercial and clinical trial material. Personnel in the following fields should attend:QA/QC
Regulatory Affairs
Commercial Production
Process Development
Pilot-Plant Operations
Auditing
Validation
Management Regulatory agency investigators who inspect API operations and facilities are encouraged to attend. Registrants will benefit from individual and group discussion of compliance issues related to worldwide API production in locally regulated environments.
Description:
It is essential that API production facilities operating under local regulatory authorities in different regions consistently produce the same API that meets the quality attributes and characteristics it is intended to have. An Expert Working Group developed the ICH-Q7A document as a single standard that all suppliers should apply to production of APIs used in human products manufactured in any of the ICH signatory regions. This course also includes sections on APIs produced by cell culture/fermentation and on APIs used in clinical trials. The course will provide historical insight and specific interpretation of the requirements in the Q7A document. The Q7A document addresses all aspects of API production in 19 sections and each of these sections will be critically examined in detail during the course. At the end of the first day is a discussion period between faculty and registrants to clarify points and exchange information with colleagues. Also included is a workshop in which registrants are asked to apply what they have learned to resolve issues in test cases based on actual FDA-483 observations.
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