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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
26-27 September 2016
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. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Richard G. Einig, Ph.D., RAC, CQA; Pharmaceutical Quality Assurance Consultant |
Richard G. Einig, Ph.D., RAC, CQA is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory and development units of large international companies and start-up “biotechs”. He has worked internationally with API production facilities, innovator and generic dosage form companies, medical device manufacturers and research organizations.
Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee’s Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products.
Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and PhD from Missouri University.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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jmorbit@cfpa.com
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The faculty has extensive experience in API production and they offer their personal insights and analysis into the requirements in the Q7 document. They will provide the historical basis for the requirements along with the risk analysis principles espoused in the recent ICH-Q11 document.
Since the Q7 document addresses all aspects of API production in 19 sections, these serve as the framework for the course. Each of these sections will be described and critically examined by the faculty. There are two group discussions to clarify individual issues and afford an opportunity to exchange information among colleagues. A workshop is also included in which registrants are asked to apply what they have learned to resolve issues in test cases based on actual FDA-483 observations.