FDA Inspections Need Not Be Stressful
A Complion Feature Article
As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.
Access this feature article today and learn:
- How FDA inspections work
- Everything you should know about the examination of FDA Form 483
- What you need to be prepared for a FDA inspection
- Examples of the most common problems cited during FDA audits and how to avoid them
Access the article today!
Dr. Harvey Arbit received his bachelor’s degree in pharmacy from Albany College of Pharmacy, PharmD from Duquesne University and MBA from Northern Illinois University. He completed a residency in clinical hospital pharmacy at Mercy Hospital in Pittsburgh, Pennsylvania.
He joined the pharmaceutical industry straight from graduate school and has spent over 30 years there in the areas of regulatory affairs, clinical research, quality assurance, and product development. Dr. Arbit is an active member of several professional associations in pharmacy, regulatory affairs and clinical research. He has his Regulatory Affairs Certification (RAC) through RAPS and Clinical Research Professional Certification (CCRP) through SoCRA. He has served as a board member and officer of SoCRA.