Course Description

FDA Drug Approval, Regulation and Compliance

This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or for more information.

Course ID 587

In-Person Course

Who Should Attend?
Because of its comprehensive content, this course should prove most valuable to:

  • Regulatory Affairs Professionals
  • QA/QC
  • Scientists/Laboratory Staff
  • Supervisors
  • Engineers
  • Management
  • New Drug Project Management
  • Legal Staff
  • Manufacturing Personnel

Those who are new to the industry or to their current position and do not have an in-depth knowledge of the FDA and its workings will benefit from this course. The program provides an opportunity for more experienced personnel, including middle and upper management, to update and broaden their knowledge.

Course Description
This continually updated course covers current FDA drug development issues and compliance with respect to marketing human drugs and biologics, including NDAs, ANDAs and other pre-approval documents, the FD&C Act, case law, and the FDA’s authority to promulgate and enforce regulations. Among the topics to be discussed will be: FDA’s regulatory policies, how they develop and where they are documented; the regulatory process, including regulatory and pre-approval inspections, recalls, warning letters, injunctions, seizures and criminal prosecutions; cGMP; compliance programs, how they develop and are administered; compliance policy guides; the Regulatory Procedures Manual and the Inspection Operations Manual. Laboratory and Process Validation, Stability, the Establishment Inspection, the FD-483 and interactions with FDA’s inspectors (investigators) will also be discussed. The course will have applications to RX and OTC drugs and biotechnology-derived products.

Course Director
Gary L. Yingling, Esq.; Senior Counsel, Morgan, Lewis & Bockius

Gary L. Yingling, Esq. is Senior Counsel in the Washington, DC office of Morgan, Lewis & Bockius. His practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics working with the FDA, USDA Food Safety Inspection service and various states. His work has ranged from ingredient safety questions, preparing INDs, to product labeling with particular interest in clinical research/contract research organization/sponsor matters.

Former president of the Food and Drug Law Institute and Director of the Over-the-Counter (OTC) Drug Review, Mr. Yingling received FDA’s Award of Merit, the agency’s highest award, for his legal and administrative work on the OTC Review. He is a registered pharmacist in Maryland and the District of Columbia.

Mr. Yingling earned a B.S. degree in Pharmacy from the University of North Carolina, a M.S. degree from Purdue University, and his J.D. from Emory University. His court admissions are to the US District Court for the District of Columbia and the US Supreme Court. He is co-author of the Guide to Good Clinical Practice.

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