Excipient GMP Auditing Workshop

Workshop Information:

This workshop for makers and users trains auditors in assessing excipient manufacturers conformance to appropriate GMP requirements.

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:

• Assessing GMPs for Excipient Manufacture
• Where GMPs Begin
• Audit Planning
• Pre-audit Questionnaires
• Alternative Audit Approaches
• Audit Checklists & Techniques
• Necessary Auditing Interpersonal Skills
• Defining Pertinent Audit Issues In Observations
• Writing & Rating Observations
• Hands-On Mock GMP Audit