Auditing / Self-Inspection

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

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
  • Writing and managing of a program
  • Implementation of a program
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 Nuts and Bolts of an Audit
  • Failures of auditors
  • Failures of auditees
  • Differences between European and FDA audits
16.00 - 17.00 Content of an SOP
Qualification of Auditors
17.00 - 17.30 Discussion

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