IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients

Tuesday, November 17, 2020 - 9:30am

Free registration for IPEC-Americas members.

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The presenters will provide an overview on soon to be published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients:

Lack of a unified  industry approach to Certification Body (CB) qualification, results in each pharmaceutical company independently developing an approach, which would be subject to  scrutiny during a regulatory agency inspection. Some pharmaceutical companies are reluctant to develop one on their own and without one are unwilling to accept 3rd party excipient GMP certification, which places additional audit burden on excipient manufacturers. This webinar will provide a method for qualification of Scheme Owners and Certification Bodies that excipient users will find useful in their selection of a Certification Body.

Learning Objectives

Attendees will be able to:

• Define qualification expectations for certification scheme (CS) owners and certification bodies (CBs)
• Identify information needed by excipient users to qualify CS Owners and CBs who conduct and issue excipient GMP certificates and audit reports
• Become familiar with content and use of the Qualification Template

Presenter(s)

Katherine Ulman

KLU Consulting, LLC

Katherine Ulman retired from Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, after more than 40 years of employment. There she held positions as a global regulatory compliance manager for their healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.

 

Irwin B. Silverstein, Ph.D.

Lead Trainer
IPEC-Americas Excipient Learning Lab

Dr. Irwin B. Silverstein.  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. Since 1991, he has worked 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.

Cancellation Policy

Note:

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
E-mail: ipecamer@ipecamericas.org

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.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org