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The Center for Professional Advancement, New Brunswick, NJ
May 14-16, 2008
Who Should Attend
This course is for individuals working in all phases of human and veterinary Active Pharmaceutical Ingredient (API) production and control including:- QA/QC
- Pilot and Commercial Production
- Auditing
- Engineering
- Validation
- Technical Services
- Regulatory Affairs
- Process Development
Corporate managers benefit from opportunities the course offers for individual and group discussion of compliance issues. Regulatory Agency Investigators are encouraged to attend. Description
This course will prepare you to meet the varied challenges now facing the global active pharmaceutical ingredient industry. It is important that API production facilities operating under different national and international regulatory authorities not be required to meet diverse standards. For this reason an Expert Working Group in ICH developed the ICH-Q7 document as a single standard that all suppliers must apply to production of APIs used in human drug products manufactured in any of the ICH signatory regions.
This course will provide historical insight into the development of the Q7 document and specific interpretation of requirements in the document. The Q7 document addresses all aspects of API production in 19 sections, and each of these sections will be examined in detail during the course. Throughout the formal presentations participation by the registrants is welcome. There are interactive exercises periodically spaced through the first two days that allow registrants to analyze real life situations that occur in typical operations. These afford an opportunity to exchange information and approaches with colleagues. The final activity is a workshop in which registrants are asked to apply what they have learned to resolve issues in test cases.
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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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