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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
27-29 June 2012
Who Should Attend
This course is for individuals working in all phases of human and veterinary Active Pharmaceutical Ingredients (API) production including:
• Pilot and commercial production
• QA/QC
• Technical services
• Regulatory affairs
• Process development
• Validation
• Regulatory agency investigators
The presenters discuss requirements for a GMP compliant API operation, everyone's role in achieving compliance and penalties for noncompliance. Description
This course prepares attendees to meet the challenges they face in the heavily regulated pharmaceutical industry. API manufacturers must ensure that GMP principles are applied to API production and there is extensive focus on relevant operational, control, and regulatory activities with specific examples. This information is essential for successfully meeting GMP requirements that are sometimes only incompletely expressed by official regulatory guidance documents including ICH Q7.
Some of the topics discussed are design, construction and qualification of GMP production facilities; selection, qualification and cleaning of equipment; process development and technical transfer; validation principles and process validation. Regulatory agency compliance oversight, and duties of the quality unit to establish and manage systems required to maintain compliance will be discussed. Throughout the program there are interactive class exercises. On the last day of the course, participants receive instructions 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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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 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 Ph.D. 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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sberg@cfpa.com
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