Preparing for a Regulatory Inspection

£1070 + VAT

20th - 21st November 2008

This course examines why we need to prepare for a regulatory inspection, even if we believe that we have a fully compliant operation.

Although the principles covered apply to any inspection, from in-company to third party to regulatory authority, differences in practice and behaviour between various pharmaceutical regulatory inspectorates are covered (e.g. EU vs FDA).

It is a highly interactive course aimed at pharmaceutical professionals who wish to increase their understanding of the mechanics and dynamics of the inspections process.

Couse contents:

• What are the regulations
• Why do authorities inspect
• Types of inspection
• How to prepare for the inspection
• How to organise for the inspection
• How to manage the inspection
• Conduct during inspection - the do's and don'ts
• How to respond to inspectors concerns
• Follow up and closure of commitments

To book a training course, please download the booking form, complete and email to bookings@rssl.com