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Overview

A UL course

FDA inspects the facilities of the sponsors or their contractors who conduct bioequivalence studies, under the In Vivo Bioequivalence Compliance Program. It is one of the seven compliance programs of the Bioresearch Monitoring (BIMO) Program. Included in the FDA inspections are the clinical facilities where bioequivalence studies are conducted (i.e., subjects are enrolled, dosed, and biological samples are collected) and analytical facilities where biological samples are analyzed to determine the concentrations of the drug. This course will introduce you to the challenges of inspecting clinical and analytical facilities and the various technical terms commonly used in bioavailability and bioequivalence studies.

Featured topics

  • Part 11
  • Basic and security requirements for electronic records
  • Basic requirements for electronic signatures
  • Controls for electronic signatures
  • FDA enforcement of Part 11

Who should attend?

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

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