How FDA Inspection Observations are Reviewed for Regulatory Action

Duration: 60 Minutes
The presentation covers the different steps in processing observaions and evidence collected during an inspection for possible regulatory action.
Regulatory Action
Instructor: Luis Chavarria
Product ID: 500069
Hundreds of Domestic and Foreign Companies are inspected by the FDA and the inspection result in regulatory actions that greatly impact the firm's reputation and business. Learn what steps are involved in the process.

Why Should you Attend:
All Regulatory Affairs Staff, Company Managers, and any staff that interacts with the FDA.

Objectives of the Presentation:
Prepare the company to deal with the development of possible regulatory action.

Who can Benefit:
  • Regulatory Staff
  • Company Managers
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$375
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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
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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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