| 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 |