Basic GMP Course: Regulatory and GMP Requirements for Pharmaceutical Companies

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

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

  Content Day 1
8.30 - 8.45 Introduction / Expectations of the participants
8.45 - 9.45 Regulations in Europe
9.45 - 10.00 Coffee
10.00 - 10.45 Regulations in the USA
10.45 - 11.30 Other Regulations and Guidances
11.30 - 12.30 GMP in Manufacturing - Hygiene
12.30 - 13.30 Lunch
13.30 - 14.15 GMP in the technical area
14.15 - 15.15 Good Documentation Practice
15.15 - 15.30 Coffee
15.30 - 16.30 GMP in Quality Control
16.30 - 17.00 Discussion, Q&A

 

  Content Day 2
08.30 - 09.30 Change Management
09.30 - 10.15 Risk Management
10.15 - 10.30 Coffee
10.30 - 11.30 Training & Self Inspections
11.30 - 12.30 Qualification, Calibration, Validation
12.30 - 13.30 Lunch
13.30 - 14.30 Data Integrity
14.30 - 15.30 What are critical data?
15.30 - 15.45 Coffee
15.45 - 16.30 Findings during Health Authority Inspections
16.30 - 17.00 Discussion, Q&A

 

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