Course Description

FDA Drug Approval: Regulation and Compliance: Including Inspections, Manufacturing Controls (cGMPs)

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Course ID 2950

In-Person Course

Who Should Attend?
Because of its comprehensive content, this course should prove most valuable to:
- Regulatory Affairs Professionals
- 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.

This 12-hour training event will have applications to RX and OTC drugs and biotechnology-derived products.

Course Director
Gary Yingling, Esq, Wiley Rein, LLP

Gary Yingling, Senior Counsel with Wiley Law, Washington DC, focuses his practice on issues involving the U.S. Food and Drug Administration (FDA), with a particular interest in clinical research, contract research organization and sponsor matters. He has also represented clients in matters involving the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), the U.S .Environmental Protection Agency (EPA), the U.S. Consumer Product Safety Commission (CPSC), the Federal Trade Commission (FTC), and various states. He has represented numerous clients in cases involving labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. Mr. Yingling is a frequent speaker on FDA regulatory issues and received the FDA’s Award of Merit in 1974 for legal review of the organization’s over-the-counter review process. He also served as president of the Food and Drug Law Institute, and was a recipient of the FDLI Distinguished Service and Leadership Award. Mr. Yingling received his J.D. from Emory University School of Law; his M.S. from Purdue University and his B.S from University of North Carolina. He currently holds Bar and Court Memberships with the District of Columbia, U.S. Supreme Court and U.S. District Court for the District of Columbia.

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Course Director
Bonnie M. Pappacena, President, Qualture LLC

Bonnie M. Pappacena is the President, Qualture LLC, a Quality consulting firm committed to building Quality into company culture. Ms. Pappacena has been a Quality professional for over 35 years spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies and commercial products), and GVP regulated areas. She is well versed in building quality teams to provide independent, effective quality oversight for regulated areas.

Prior to establishing Qualture LLC, Ms. Pappacena was Vice President, Quality at Foamix Pharmaceuticals. She also held the position of Vice President Quality at G&W Laboratories and Acorda Therapeutics. Ms. Pappacena was also employed as a Quality professional while at Schering Plough, Lederle, SmithKline Beecham Animal Health, and Monsanto.

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