Content Day 1 | |
08.00 – 08.30 | Welcome and Introduction |
08.30 – 10.00 | Regulatory Requirements for the Manufacturing of the Active Pharmaceutical Ingredients
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10.00 – 10.15 | Break |
10.15 – 12.15 | The Quality Management System
|
12.15 – 13.15 | Lunch |
13.15 – 14.30 | Risk Management, ICH Q 9
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14.30 – 16.30 | Qualification/Validation
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15.30 – 15.45 | Break (in between) |
16.00 – 17.30 | Quality Control
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17.30 – 18.00 | Final Discussion |
Content Day 2 | |
08.00 – 08.30 | Remarks, Questions; Proposals |
08.30 – 09.30 | Facility and Material Management
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10.30 – 10.45 | Break |
10.45 – 12.45 | Manufacturing of the API
|
12.45 – 13.45 | Lunch |
13.45 – 14.45 | GMP in Research and Development
|
14.45 - 16.00 | Documentation
|
15.15 – 15.30 | Break (in between) |
16.00 – 17.15 | Auditing and Self- Inspection
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17.15 – 17.45 | Discussion |