FDA Inspections Need Not Be Stressful
Presented by: Harvey M. Arbit, PharmD, MBA, RAC, CCRP
This webinar will walk the attendee through the FDA inspection process: pre-inspection, during the inspection, post inspection and beyond. Instruction will be provided to assist in responding to the observations listed in the Form FDA 483. Examples of warning letters will be presented, highlighting some of the most common violations.
After watching this webinar, you'll learn:
- A 360-degree understanding of how FDA inspections work
- A thorough 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
Presented by: 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.
Access the on-demand webinar today!