FDA vs EU Inspections - Getting Prepared and What are Differences

Duration: 60 Minutes
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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 Inspection Process
Instructor: Marie Dorat
Product ID: 501232
Objectives of the Presentation
  • 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
Why Should you Attend
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.

Who can Benefit
  • Quality Assurance Managers and Auditors
  • Regulatory Affairs
  • Document Management
  • Other professionals who want to know more about inspection guidelines
$375
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Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP 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 positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site 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 provides training courses both for 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,.
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