RSS Newsfeed  Your shopping cart.
ECA Academy - Your GMP/GDP Information Source

Search in



In-house Training Programme


Auditing / Self-Inspection

When What
8.00 - 8.30 Welcome, Introduction, Presentation of the Speaker
8.30 - 9.30 Regulatory Requirements
  • GMP
  • CFR
  • Harmonised Requirements
  • Differences between audit and self-inspection
9.30 - 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
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal 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.


 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Medical Devices
 GMP Basic Training Courses