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The Center for Professional Advancement, Den Haag, The Netherlands
28-30 May 2008
Who Should Attend
This course is intended for chemical manufacturers who want to learn about supplying excipients to the industry and for those manufacturers already supplying excipients that need to learn about excipient GMP compliance. It is also intended for pharmaceutical manufacturers that must assess the compliance of their excipient suppliers to appropriate GMP requirements.
Personnel in the following areas have found this course beneficial:- Quality Assurance
- Quality Control
- Regulatory Affairs
- Quality Audit
- New Business Development
Description
This course will cover the regulatory, quality, and manufacturing issues involved in providing chemicals for use as excipients (inactive ingredients) in the manufacture of drug products.You will learn about the regulation of chemicals sold for use as excipients by the FDA, the expectations of the pharmaceutical industry, and excipient quality system requirements (GMP). There will also be topical information on current issues facing the industry.
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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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Irwin Silverstein, Ph.D.; President, IBS Consulting in Quality LLC., Chief Operating Officer, International Pharmaceutical Excipients Auditing Inc.
Irwin Silverstein, Ph.D., is President of IBS Consulting in Quality LLC and Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc. He has spent 25 years in the industry including 17 years as the head of Corporate Quality for International Specialty Products Inc. Dr. Silverstein has spent over 16 years working with the International Pharmaceutical Excipients Council developing the excipient GMP guidelines as well as other guidance documents and has authored several articles on various aspects of the subject. He has given many seminars on excipient GMP compliance to the industry as well as to the Food & Drug Administration.He is the author of chapters on excipient topics in "Validation of Active Pharmaceutical Ingredients", "Pharmaceutical Dosage Forms: Disperse Systems", "Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems" and "Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control".
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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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