Preparing for Regulatory Inspections

Preparing for Regulatory Inspections Course.

This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organisation. You will understand what regulatory authorities are and what they do, and then learn how they conduct inspections and the key information they are looking for.  The learning outcomes for the course are as follows:

• Recap on the basics of ICH GCP focusing on the R2 addendum
• Gain a knowledge of the cascade of regulations that exist
• Understand the responsibilities of the regulatory authorities
• Recognise the different types of inspection and what the inspectors inspect against
• Understand the general inspection process
• Understand what an inspection dossier and inspection plan is
• Understand how to assure compliance to regulations
• Recognise what you must do to prepare for an inspection
• Know how to prepare your work area before the Inspector arrives
• Understand how to interact with the Inspector
• Recognise some of the typical Data Management findings from inspections