Failure to anticipate, find and correct compliance problems before site inspection can result in unnecessary Observations, possible Warning Letters, or worst, and a competitive “hit” in the market place.

_{^{Target Group}}

This GMP Education Course is designed for all persons involved in conducting, preparing and evaluating audits and inspections.

It is also addressed to interested parties from regulatory authorities.

_^Outlines

• The Challenges of GMP Audits
• Regulatory Requirements
• Purposes and Reasons for GMP audits
• Audit types
• Preparing and performing a GMP audit
• The One-day Audit - How to get a quick Assessment of a Company State of Compliance
• What makes a good inspector?
• How to make a risk-based Audit Schedule?
• Preparing for a GMP Inspection
• What do authorities expect?
• Preparing for a Regulatory Inspection