ReflectionPlease review the Module 8 materials for this course including the “Enforcement Examples” (Reading), FDA compliance databases (e.g., FDA Form 483 Inspections, Warning Letters, Compliance Data Dashboard, and Clinical Investigator Disqualification) (Mixed Media), and the CDER Learn training “World of Compliance” (Mixed Media). Completed Assignments should be submitted using the Blackboard Assignment Tool. Instructions Using the Course Discussion Forum “Module 8 – Enforcement Example Reflection” provide a brief critical reflection on 1 of the 4 “Enforcement Examples” considering what you learned from the CDER Learn training “World of Compliance” and your review of the FDA compliance databases.Enforcement Examples
McGee GCP DisqualificationsHow does the training you took apply to the example(s) you evaluated? (indicate the specific enforcement example you are discussing)
Do you agree with the actions/outcomes of the FDA enforcement based on the training and evaluation example(s)? Explain why or why not.
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