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The Center for Professional Advancement, Amsterdam, The Netherlands
2-4 June 2008
Who Should Attend
This course is for individuals working in all phases of human and veterinary Active Pharmaceutical Ingredients (API) production and control including:- Pilot and commercial production
- QA/QC
- Regulatory affairs
- Process development
- Engineering
- Management
The course models a GMP compliant API operation, everyone’s role in achieving compliance, and penalties for noncompliance. Government investigators who inspect API operations are encouraged to attend. Description
This course prepares attendees to meet the challenges they face in this heavily regulated industry. It is vital for API producers to ensure that GMP principles are applied to API production and control, and to demonstrate knowledge of FDA, ICH and other governmental and industry guidance documents.
This course will provide guidance in the design, construction, and validation of GMP pilot and production facilities. Examples of facilities will be discussed. The selection, qualification, and cleaning of equipment will be included with specific examples. Process validation is of singular importance and validation principles and their application will be demonstrated with examples. Process development and technical transfer reports will be described. The function of the quality unit to establish and manage the systems required to maintain compliance will be discussed. Throughout the program there will be interactive class exercises. On the last day of the course participants will receive instruction on managing an FDA inspection followed by a workshop in which participants prepare written responses to simulated FDA-483s (List of Inspectional Observations) based on actual FDA observations. The exercise will result in a valuable exchange of information and approaches with your colleagues.
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Organized by:
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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 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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info@cfpa.com
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