This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
FDA and EU GCP regulations and standards apply pharmaceuticals, biologics and medical devices. Failure to conform to these requirements may result in concerns about quality and integrity. Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection and audit process are critical activity. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.
This webinar has been specifically designed to help attendees prepare for FDA and EU inspection. 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 through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.
- Differences between FDA and EU Inspections including the FDA and EU joint inspection programmer
- How to prepare for EMA and FDA audit
- How to plan for an audit or inspection using checklists/ FDA/EMEA inspection guidelines
- Tips for employees before the inspect
- Tips on proper responses to prepare for audit/inspection Interviews
- Setting up a Triage to ensure that required documents are available
- How to interact with the inspectors-DO’s and DON’Ts
- How to reply to inspection reports, 483’s and EU inspection finding
- Post inspection actions – implementing appropriate CAPAs in response to audit findings
- Quality Assurance Managers
- Quality Auditors
- Regulatory Affairs Teams
- Document Management Teams
- Professionals who want to know more about inspection guidelines