|
|
| QUALITY RISK MANAGEMENT (QRM) TRAINING for GMP inspectors |
Day 1 |
|
|
| 8:30 - 9:00 | Registration |
| 9:00 - 9:05 | Welcome |
|
9:05 - 9:10 | Opening session |
|
9:10 - 9:50 | Relevance of ICH Q8, Q9, Q10 (interrelationship) |
|
9:50 - 10:20 | Basic Introduction to QRM / ICH Q9 Definitions |
| 10:20 - 10:50 | Coffee break |
|
10:50 - 11:30 | Risk assessment methods and their limitations |
|
11:30 - 12:00 | Fields of application of QRM |
|
12:00 - 12:30 | Q&A session |
|
12:30 - 13:30 | Lunch |
|
13:30- 14:00 | Aide memoire for QRM inspections |
|
14:00 - 14:15 | Q&A session |
|
14:30 - 15:00 | QRM models for inspectorate |
|
15:00 - 15:30 | Q&A session |
|
15:30 - 16:00 | Coffee break |
|
16:00 - 16:30 | Introduction to case studies |
|
16:30 - 17:00 | Feed-back on the first day training |
|
|
|
QUALITY RISK MANAGEMENT TRAINING for GMP inspectors |
|
Day 2 (workshop / case studies) |
|
|
|
9:00 - 11:00 | Introduction / Workshop on case studies (group I, II and III divided in sub-groups) |
|
11:00 - 12:15 | Sharing of results and exchange of ideas (in each group)
(Coffee will be available from 10:30 to 11:30) |
|
12:15 - 13:00 | Preparation of materials for afternoon session |
|
13:00 - 14:00 | Lunch |
|
14:00 - 14:30 | Group I presentation and facilitator review and comments |
|
14:30 - 15:00 | Group II presentation and facilitator review and comments |
|
15:00 - 15:30 | Group III presentation and facilitator review and comments |
|
15:30 - 16:00 | Break |
|
16:00 - 17:00 | Feed back and discussions / Next steps |
|
|
