הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
Regulatory inspection findings and requirements at suppliers / manufacturers / brokers
Scheduling audits using risk-based thinking
The audit agenda:
Conducting the audit: educating instead of criticizing; listen but cut off long
discussion – this is the right way…maybe?
Wrap up meeting – : do’s and don’ts and commitment to actions
Report writing
CAPA: how to get effective responses and follow up on implementation of corrective actions; escalation
What happens if they correct the finding without addressing the root cause(s)?
Audit close out
Interactive exercise: simulation of an audit: various scenarios
Detailed Agenda
08:30 – 09:00 | Registration and Breakfast |
09:00 – 10:00 | Inspection findings and regulatory requirements for supplier audits: ICH Q10, EU chapter 5; 21cfr 211? |
10:00 – 10:30 | Scheduling audits: risk-based thinking |
10:30 – 11:00 | Coffee break |
11:00 – 12:30 | Audit agenda |
12:30 – 13:30 | Lunch break |
13:30 – 14:450 | Simulate audits in small groups each with a case-study to discuss and work through – present findings to class |
14:45 – 15:00 | Tea break |
15:15 – 16:30 | Wrap up meeting, report, responses and escalation |
16:30 – 17:00 | Workshop wrap up, Q&A |
בסיומו של יום העיון יהיו בידי המשתתפים כלים לעריכת:
הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)