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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
Schedule of Virtual Sessions
Monday, May 23 - 10:00am-2:30pm ET
Tuesday, May 24 - 10:00am-4:00pm ET
Wednesday, May 25 - 10:00am-4:00pm ET
Thursday, May 26 - 10:00am-4:00pm ET
> Timing is tentative and will be based on the time zone of participants.
> Agenda will be available soon.
A mock-audit session is scheduled for Wednesday morning May 25, which is a highlight of the workshop. Please keep this in mind you will not want to miss this important hands-on activity! Discussion and findings about the mock audit session will take place Thursday Wednesday.
A copy of the NSF/IPEC/ANSI - 363 standard is available for purchase from either the NSF or ANSI web sites for a fee of $165. The standard is not provided to course participants.
Please do not hesitate to contact us if you have any questions at all,