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Excipient
GMP Auditor Workshop
IPEA
offers workshops which train auditors in assessing
excipient manufacturers compliance to appropriate
GMP requirements.
Next tentative Auditor Workshops are:
Houston 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,
Click here
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