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