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Training and Workshops

Excipient GMP Auditor Workshop
IPEA offers workshops which train auditors in assessing excipient manufacturers compliance to appropriate GMP requirements.

Next tentative Auditor Workshops are:
H
ouston September 23 - 25, and St. Louis December 2 - 4.

Basic Excipient Auditing
This workshop is designed to train personnel to conduct audits of excipient facilities.
It includes the topics covered in the workshop Auditing the Excipient Manufacturer
below plus:

  • Overview of Auditing
  • Pre-Audit Planning
  • Audit Activities
  • The Audit Report
  • IPEC Reference Materials
  • IPEC GMP Guide
  • IPEC Audit Guides
  • Excipient Audit Program
  • Audit Documentation
  • Excipient SOPs

Auditing the Excipient Manufacturer
This workshop is meant for personnel already trained to perform audits but who are unfamiliar with auditing excipient manufacturers. It includes discussion of the following topics:

  • Qualifying an Excipient Supplier
  • Regulatory Requirements
  • Uniqueness of Excipients
  • Where does GMP start?
  • Assessing Excipient Supplier GMP Conformance
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis and Improvement
  • General Auditing Considerations

IPEA workshops are limited to 20 participants.
To be notified first before the next workshop,
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