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Home Blog FDA Inspections

Category Archive

Below you'll find a list of all posts that have been categorized as “FDA Inspections”

eReg Binder

eRegulatory Binder Checklist: What Does the FDA Require?

Joe Wochna 12/01/2021 eRegulatory, FDA Inspections, Regulatory Binder

eRegulatory binders help clinical sites organize and digitize the regulatory process, but each binder is different depending on the specific clinical trial site protocol. Here, we provide an overview of the specific sections and documents that must be included for an FDA-regulated study.

FDA inspections don't need to be stressful

FDA Inspections Need Not Be Stressful: Q&A with Dr. Harvey Arbit

Joe Wochna 09/28/2020 FDA Inspections, Regulatory Compliance

This Complion question and answer session held with Dr. Harvey Arbit, an adjunct professor at the University of Minnesota College of Pharmacy, provides insights into achieving stress-free FDA inspections.

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Recent Posts

  • Complion Visits Texas for SCRS Global Oncology Summit
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