| 8.00 - 8.30 |
Welcome, Introduction,
Presentation of the Speaker |
| 8.30 - 9.30 |
Regulatory
Requirements
- GMP
- CFR
- Harmonised Requirements
- Differences between audit and
self-inspection
|
| 9.30 - 10.30 |
Audit Program
- Writing and managing of a
program
- Implementation of a program
|
| 10.30 - 10.45 |
Break |
| 10.45 - 11.45 |
Preparation for an
Audit
- Internal and external
preparation
- Communication with the auditor /
auditee
- Internal and external planning
of an audit
|
| 11.45 - 13.00 |
Realisation of an
Audit
- Audit plan
- Introduction
- Performance of an audit
- Questions and answers
|
| 13.00 - 13.45 |
Lunch |
| 13.45 - 14.45 |
Audit Report
- Wrap-up meeting
- Writing an audit report
- Follow-up of findings
- 483'er / Warning letter
|
| 14.45 - 15.00 |
Break |
| 15.00 - 16.00 |
Nuts and Bolts of an
Audit
- Failures of auditors
- Failures of auditees
- Differences between European and
FDA audits
|
| 16.00 - 17.00 |
Content of an SOP
Qualification of Auditors |
| 17.00 - 17.30 |
Discussion |
