Revised Compliance Program 7346.832 – Pre-Approval Inspections

Revised Compliance Program 7346.832 – Pre-Approval Inspections

by

CDR Chad N. Thompson
(FDA)

This presentation will provide an overview of the USFDA pre-approval inspection compliance program 7346.832 applied during pre-approval inspection coverage and highlight the recent revision made effective on October 17, 2022.  The revision added elements of the ICH guidance for industry, impurity risk assessment and the use of alternative tools in lieu of and in advance of inspections.  Fundamental knowledge of this compliance program will aid in the preparation of pre-approval inspections.

 

Date and Location

Dec 1st, 2022

5:30 PM

Meeting Sponsors

BASF

Quotient Sciences

Seasons

644 Pascack Rd, Township of Washington, NJ 07676


About the speaker

CDR Thompson is currently a Director of Investigations Branch in the Office of Pharmaceutical Quality Operations Division 1. CDR Thompson joined FDA in 2008 and was a drug investigator in the Albany, NY resident post of the New York District where he conducted domestic and international pharmaceutical and biotech inspections. He became a supervisor in 2016 and in 2017 was aligned into Pharma Division 1.

CDR Chad Thompson commissioned as a Health Services Officer with the Public Health Service while an investigator for the FDA in 2009. CDR Thompson was a member of RIST 2 deployment team and has deployed multiple times during the COVID-19 Pandemic, Operation Allies Welcome, hurricanes and regional incident support. Prior to FDA, he worked in the pharmaceutical industry as an R&D combinatorial chemist and analytical stability project manager. CDR Thompson earned a B.S. in Chemistry from Gardner-Webb University and an M.S. in Chemistry from the University of Albany.

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