- Regulatory requirements for excipient GMP in the U.S. and Europe
- Significant new requirements in the new ANSI Excipient GMP Standard - overview and details, plus review of changes made in ANSI 363-2016
- Audit expectations of these new requirements to facilitate gap assessment
- Introduction to IPEC resources - what's available, where to find them, how to use them
- Important differences between NSF/IPEC/ANSI 363 and IPEC-PQG Excipient GMP
Who Should Attend
Individuals and groups within the pharmaceutical, dietary supplements and other excipient manufacturing and consuming industries who have the need or desire to understand and apply the NSF/IPEC/ANSI 363 standard to their business, such as those involved in:
- Quality (excipient or finished dosage form);
- Manufacturing (excipient or finished dosage form);
- Regulatory Affairs;
- Purchasing / procurement of excipients;
- Excipient marketing or sales
- Gain awareness and understanding of and distinguish between the details of requirements of NSF/IPEC/ANSI 363 Excipient GMP Standard and those of the IPEC-PQG Excipient GMP Guide.
- Name, use, locate and apply IPEC resources (IPEC Guides, white papers, training, etc.) that are useful in performing a gap assessment against the new Standard.
Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked since 1991 with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration. Dr. Silverstein established an excipient GMP certification program that was accredited by the American National Standards Institute (ANSI) and ran the program from 2001 till 2014.
His recent consulting has broadened to include pharmaceutical firms where he assesses conformance to site requirements. 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. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed the IPEC-Americas auditor training programs for hourly and supervisory personnel. Irwin is also serving as leader of the IPEC-Americas Excipient Learning Lab (ELL).