cGMP for Investigational New Drugs (IND) in Phase I Clinical Trials

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. All drugs manufactured for use in clinical trials must comply with Good Manufacturing Practices. Drugs for Phase I clinical studies must comply with statutory CGMP. Drugs for human use must not be adulterated. The manufacturer must assure the drug is safe and has the identity, strength, quality, and purity which it is represented to possess. The FDA's guidance document covering this topic will be discussed.

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 FDA's guidance document covering CGMP for clinical trials .

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


Recorded 10/15/2012
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10 Questions  |  Unlimited attempts  |  8/10 points to pass You must have a passing score of 80% to receive your CE certificate.
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1.00 CE credit  |  Certificate available
1.00 CE credit  |  Certificate available