Topics
- How to prepare for EMA and FDA audit regulatory affairs and clinical trials
- Differences between FDA and EU Inspections including the FDA and EU pilot joint inspection programmer
- Ways to train employees in view of the inspection
- How to plan for an audit or inspection including using appropriate checklists/ FDA/EMEA inspection guidelines
- How to ensure that required documentation is in place
- How to prepare for audit/inspection Interviews
- How to reply to inspection reports and 483’s and warning letters and EU inspection finding
- How to interact with the investigator—DOs and DON’Ts
- How to carry out corrective and preventative action for responding to inspection findings
- Post inspection actions and to consider how to respond to the audit/inspection findings
Who should Attend
Professionals from EMA and FDA regulated companies such as biotechnology, pharmaceutical, SMO, CRO, vendor companies, or study sites including investigator initiated studies that are subject to audit or inspection.
