Supplier Qualification - Considerations for Excipient Makers and Users

Wednesday, January 17, 2018 - 11:00am

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This webinar, originally recorded on January 14,2018, is an overview of the IPEC guide Qualification of Excipients for use in Pharmaceuticals. It reviews the general guidance section with emphasis on the regulatory assessment, manufacturing and packaging, and excipient specifications.

Presentation Objectives

For Excipient Makers:

Customer expectations for their product and the expectations for supporting information

Excipient development for use in finished product and specification requirements (so that the excipient manufacturer understands the information required by the user)

For Excipient users:

The supplier qualification process for the pharmaceutical manufacturer (excipient user) - includes assessment, selection, and specification development


Irwin B. Silverstein

Lead Trainer
IPEC-Americas Excipient Learning Lab

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).

Cancellation Policy


Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Please contact IPEC-Americas Training Coordinator
571-814-3450 or email