FDA vs. EU Inspections - How to Prepare and What are the Differences 2013
12 Nov 2013
Webinar
Key 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.
Past Events
FDA vs. EU Inspections - How to Prepare and What are the Differences 2013 - 12 Nov 2013, Webinar (40986)
FDA vs. EU Inspections - How to Prepare and What are the Differences 2026
Important
Please, check "FDA vs. EU Inspections - How to Prepare and What are the Differences" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical laboratories, Pharma
