This workshop will be held virtually.
For more information and to register!
Save When You Bring Your Team
Register your staff using the same email domain to take advantage of our "Buy 5 get 1 Free" offer and 10% off each additional attendee after the 6th. For more information contact ipecamer@ipecamericas.org.
Schedule of Virtual Sessions
Monday, Nov 14 - 10:00am-2:30pm EDT
Tuesday, Nov 15 - 10:00am-4:00pm EDT
Wednesday, Nov 16 - 10:00am-4:00pm EDT
Thursday, Nov 17 - 10:00am-4:00pm EDT
Timing is tentative and will be based on the time zone of participants.
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.
After completing this hands-on, interactive workshop:
> 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.
This workshop is the best place to:
> 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