Workshop Information:Excipient GMP Auditor Workshop
This workshop for makers and users trains auditors in assessing excipient manufacturers conformance to appropriate GMP requirements. 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 AuditingPre-Audit PlanningAudit ActivitiesThe Audit Report PEC Reference Materials IPEC GMP Guide IPEC Audit GuideExcipient Audit ProgramAudit 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 RequirementsUniqueness of ExcipientsWhere does GMP start? Assessing Excipient Supplier GMP Conformance Joint IPEC-PQG Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients Management ResponsibilityResource Management Product Realization Measurement, Analysis and Improvement
• General Auditing Considerations

IPEA workshops are limited to 20 participants.
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