FDA vs. EU Inspections - Getting Prepared and What are Differences

Why Should You Attend:

FDA and EU GCP regulations and standards apply to pharmaceuticals, IVDs 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 with 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 inspections. It will provide a background to 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 the various types of inspections that can be carried out.

Areas Covered in the Webinar:

• 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 inspection
• 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—DOs 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

Who Will Benefit:

• Quality assurance managers and auditors
• Project management
• Consultants
• Regulatory affairs
• Pharmacovigilance
• Document management
• Legal, regulatory authorities and all other professionals who want to know more about regulations and guidelines.

Instructor Profile:

Marie Dorat, CQA,CAA is a QA/RA compliance, Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies including Pfizer, and Alere. She has lectured at conferences and on training courses on QA and GXP issues. She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to Prepare,.

Follow us :