Auditing / Self-Inspection

This is how your training course could look like:

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Please note that we need about 3 months preparation for the organisation of your in-house training course.

08.00 - 08.30 Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 Regulatory Requirements
  • GMP
  • CFR
  • Harmonised Requirements
  • Differences between audit and self-inspection
09.30 - 10.30 Audit Program / Plan
  • Writing and managing of a program
  • Implementation of a program
  • Writing and managing of an audit plan
10.30 - 10.45 Break
10.45 - 11.45 Preparation for an Audit
  • Internal and external preparation
  • Communication with the auditor / auditee
  • Internal and external planning of an audit
11.45 - 13.00 Realisation of an Audit
  • Audit plan
  • Introduction
  • Performance of an audit
  • Questions and answers

 

13.00 - 13.45 Lunch
13.45 - 14.45 Audit Report
  • Wrap-up meeting
  • Writing an audit report
  • Follow-up of findings
  • 483'er / Warning letter
14.45 - 15.00 Break
15.00 - 16.00 Knots and Bolts of an Audit
  • Failures of auditors
  • Failures of auditees
  • Differences between European and FDA audits
16.00 - 17.00

Qualification of Auditors

  • Requirements to qualify an auditor
  • GMP requirements
  • ISO 19011 requirements
17.00 - 17.30 Discussion

 

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