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Supplier Audits including workshop
Led by an experienced auditor, using case studies and role play, this interactive course / workshop allows participants to practice auditing; provides tips on scheduling; teaches what to ask; how to manage time on site; wrap-up meeting; reporting findings and following up on correction.
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Issues to be covered
Regulatory inspection findings and requirements at suppliers / manufacturers / brokers
Scheduling audits using risk-based thinking
The audit agenda:
- Documents to ask for ahead of the audit
- The audit on site
- Preparing for and conducting the wrap-up meeting
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 |
Who should attend
This course is suitable for any person involved in managing, planning, reviewing, performing or responding to or participating in GMP supplier audits. Disciplines include: purchasing, quality assurance, quality control, production personnel, logistics personnel and management involved in reviewing audit outcomes and verifying implementation of satisfactory CAPA to the audit findings.
R&D personnel involved in supplier selection for new products may find the course of value.
Benefits to the Participants
At the end of this course, participants will understand how to audit suppliers for compliance with cGMP and will have tools to conduct efficient audits for improved supplier communication and management.
About The Lecturer
