What You Should Know Before the FDA Arrives

Recorded On: 10/15/2012

This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health. This Course will discuss the steps involved in an FDA inspection and will address best practices in responding to FDA questions. The faculty will discuss what the FDA is instructed to look for when conducting an inspection and review recommendations regarding what to do after the inspection. The FDA's Compliance Program Guidance Manuals will be explained.

This is a 60 minute internet media player video of a voice over slide show.

A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.

At the completion of the webinar, participants should be able to:
1. Discuss the steps of an FDA audit.
2. Discuss how to respond to FDA questions
3. Have an understanding of the FDA's Compliance Program Manuals
4. Understand what the FDA auditor is looking for.
5. Discuss how to review recommendations from the FDA after an Audit.

Harvey M. Arbit, PharmD, MBA, RAC, CCRP

Director of the IND/IDE Assistance Program

Harvey is at the University of Minnesota Academic Health Center where he is the director of the IND/IDE Assistance Program in the Office of Clinical Research and is adjunct associate professor in the College of Pharmacy. Prior to entering academia Harvey has over 30 years experience in the pharmaceutical and medical device industries where he held director and vice president level positions in the areas of regulatory affairs, clinical research, quality assurance, and product development. He has held positions at Baxter Travenol, 3M, Upsher-Smith, SmithKline Beecham, and Coloplast.

He received his Bachelor of Science degree in pharmacy from Albany College of Pharmacy, PharmD degree from Duquesne University and MBA from Northern Illinois University. He completed a residency in clinical pharmacy at Mercy Hospital in Pittsburgh. He is Regulatory Affairs Certified and is a Certified Clinical Research Professional. Harvey also serves on the steering committee of the Clinical Trials Transformation Initiative.

He is a frequent presenter on the topic of investigator-initiated drug and device clinical research at SOCRA meetings and other venues.

SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.

Accreditation Statements:
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation

Termination Date 10/15/19

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