> Timing is tentative and will be based on the time zone of participants.

> Agenda will be available soon.

The workshop will address the following:  

Compliance with excipient GMP/GDP is important to everyone (not just auditors) involved in the manufacture, distribution or use of excipients. This workshop includes analyzing essential elements and expectations related to excipient good manufacturing practice and good distribution practices for materials intended for use in pharmaceuticals or dietary supplements. This workshop reviews the EXCiPACT Excipient GMP Certification scheme and the requirements of the updated NSF/IPEC/ANSI 363-2019.

> Participants will be able to plan, conduct and document an audit of excipient manufacturing facilities for conformance to excipient GMP expectations.

> Excipient makers will be able to assess their conformance to industry standards and guides such as NSF/IPEC/ANSI 363, EXCiPACT and the IPEC PQG GMP Guide, and remediate any gaps.

> Excipient users will be able to assess their suppliers for adequate conformance to industry standards and guides including the EU Falsified Medicines Directive (FMD) Guideline for determining GMP for excipients.

> Participants will be able to identify and remediate deficiencies in data integrity.

> Identify compliance expectations for excipient GMP/GDP

> Learn how to assess improvement needs at your own or your suppliers' facilities

> Learn how to ready your facility audit or certification audit

> Update your audit report-writing skills

> Learn how to develop reports to management to support GMP/GDP compliance

> Understand the current issues concerning the manufacture, distribution and use of excipients as identified by IPEC

Irwin B. Silverstein, Ph.D., CQA

Irwin is a consultant to IPEC-Americas 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. Irwin participated in the development of both the IPEC-PQG Excipient GMP Guide and the NSF/IPEC/ANSI 363 Good Manufacturing Practices (GMPs) for Pharmaceutical Excipient Standard.

After studying organic and biochemistry in the United States, Jeffrey Brambora started his pharmaceutical career with Eli Lilly as a manufacturing chemist, later holding multiple roles in QA, including Consultant Supplier Quality Auditor. After moving to Europe, he worked as a Senior GMP Auditor for Novartis Pharma in Basel, Switzerland. ...

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