FDA vs. EU Inspections – How to Prepare and What are the Differences
Why Should You Attend:
FDA and EU GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about data quality and integrity. Inspections are critical activities that impact business success on several levels. Therefore, preparation and management of the inspection and audit process is an important business activity, not just a distraction from day to day routine.
Potential adverse consequences to the company if an inspection does not go well range from time consuming responses to regulatory observations to publicly available warning letters, delayed product approvals, and the spectre of civil or even criminal litigation by the FDA and EU inspection agencies. These consequences are preventable with good preparation and planning.
This webinar has been specifically designed to help attendees prepare for FDA and EU inspection, particularly since such inspections are increasing and take considerable preparation time. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be taken step by step through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.
This intensive webinar will provide a concise overview of how to prepare for audits and regulatory inspection for clinical research activities carried out by EU and FDA inspectors. Attendees will hear about the findings from the joint FDA and EU inspection programme being carried out.
Areas Covered in the Webinar:
- Differences between FDA and EU Inspections including the FDA and EU pilot joint inspection programmer
- How to prepare for EMA and FDA audit regulatory affairs and clinical trials
- How to plan for an audit or inspection including using appropriate checklists/ FDA/EMEA inspection guidelines
- Ways to train employees in view of the inspection
- How to prepare for audit/inspection Interviews
- How to ensure that required documentation is in place
- How to interact with the investigator—DOs and DON’Ts
- How to reply to inspection reports and 483’s and warning letters and EU inspection finding
- Post inspection actions and to consider how to respond to the audit/inspection findings
- How to carry out corrective and preventative action for responding to inspection findings
