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The Center for Professional Advancement, An Online Training Format
October 2, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
Who Should Attend
This course will benefit professionals in all industries with special significance for the following regulated sectors: Pharmaceuticals, Food, Biotechnology, Medical Device, Dietary Supplement, Cosmetics, etc.
The information will be pertinent to personnel in the following job functions who are involved in supplier selection, qualification, or oversight: Scientists, Formulators, Auditors, Managers, Purchasing Agents
Appropriate attendees may work in the following departments: Research and Development, QA/QC, Regulatory, Purchasing Description
This 90-minute accredited online training will discuss important elements of a sound supplier qualification program. Discussions will focus on the considerations in selecting a supplier and the techniques for assessing the supplier's quality system. Special attention will be directed toward the evaluation of supplier product quality, supply chain concerns, and notification of change. This presentation will include the latest thinking by the FDA on this matter.
Module 1: SUPPLIER SELECTION
Criteria: Business relationship, Regulatory considerations, Technical expertise
Quality System requirements: ISO 9001 Certification, Food GMP, Excipient GMP
Quality System Assessment Techniques: Questionnaire, Second Party Audit, Third Party Audit
Module 2: AUDITING THE SUPPLIER
Audit Standards: ISO 9001, Food GMP, Excipient GMP
Assessment Organizations: ISO registrars, GMA Safe and AIBN, USP Certified and IPEA
Module 3: EVALUATION OF SUPPLIER PRODUCT QUALITY
Requesting evaluation samples
Process capability and Validation
Lot Selection
Notification of Change: Importance of notification, Evaluation of changes
Supply Chain issues: Purchasing from a Distributor:Distributor operations, Distributor Quality System Requirements
Identifying the manufacturer: Establishing Pedigree
Question and Answer Session
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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, President, IBS Consulting in Quality, LLC
Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in quality assurance for the API, medical device, and drug products areas.
He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked for over 17 years with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented the organization at various conferences and at the Food & Drug Administration. Of note, Dr. Silverstein is the technical consultant to IPEC for the development of their Excipient Qualification guide and assisted in the matter of Supply Chain Security for ingredients.
In addition to working as a consultant to the industry, he is the Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA). As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as an ISO 9000 Certified Lead Auditor status, he has developed the IPEA auditor-training program and has trained their auditors. He is the co-instructor of the IPEA Excipient GMP Audit Workshop. Recently, his consulting work has included pharmaceutical firms under FDA Consent Decree. Also he has audited excipient manufacturers to perform a gap analysis with respect to excipient GMP compliance and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements.
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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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