FDA Investigations and Inspections

Duration: 90 Minutes
How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.
FDA regulation
Instructor: Luis Chavarria
Product ID: 500031
Why Should you Attend:
You should attend to familiarized yourself and your staff with the specific areas, and processes covered by FDA staff during the investigations and inspections. Learn to prepare yourself in the advent of a future inspection or investigation of your company.

Objectives of the Presentation:
The objective of the presentation is to introduce the audience to the investigation and inspection process from a former regulator’s view to better prepare yourself to handle investigations and inspections.

Who can Benefit:
  • Regulatory Affairs
  • Quality Control
  • Staff in FDA regulated industries that are subject to inspections.
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  • Get certification of attendance.
$375
Recorded Session for one participant
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  • 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:
Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.

He worked in numerous offices and held numerous positions such as Consumer Safety Inspector, Consumer Safety Investigator, Supervisory Consumer Safety Investigator, Drug and Device Specialist, Program Analyst and Diplomat. He was the first foreign- based FDA attaché in the United States Embassy in Mexico City, representing the FDA in all program areas.

With more than 28 years experience with the FDA Office of Regulatory Affairs, he knows how the agency conducts inspections in all program areas and how regulatory actions are developed within the agency and within the court system. He personally conducted numerous inspections and investigations resulting in legal actions by the agency.
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