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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
22-23 October 2012
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. 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.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Mary L. Richardson; Consultant to the Regulatory Affairs Industry
Mary L. Richardson is currently a private consultant after her retirement as Vice President Regulatory Affairs at Mission Pharmacal Company. As the VP she oversaw all the company's prescription and OTC drugs, medical devices and dietary supplement production for domestic and international regulatory operations to assure compliance with all applicable requirements. Prior to this industry position, Ms. Richardson worked for twenty-one years with FDA, beginning in the New Jersey district office as a consumer safety officer. She served in the Commissioner's Office of Legislative Affairs in both the congressional oversight areas of drugs and foods and the legislative section which develops and analyzes pending legislation affecting FDA. Ms. Richardson held the position of Deputy Director in the Office of Drug Compliance in the Division of Drug Labeling Compliance for prescription and OTC drugs and as Deputy in the Division of Scientific Investigations, directing FDA activities in the bio research monitoring programs.
Gary L. Yingling, Esq.; Partner, K&L Gates
Gary L. Yingling, Esq. is a Partner with the law firm of K&L Gates. Prior to entering private practice he was, for nine years, President of the Food and Drug Law Institute. Mr. Yingling served in government for ten years, primarily in FDA’s Office of General Counsel as a trial attorney and, later, as Associate Chief Counsel for Veterinary Medicine and Deputy Chief Counsel for Administration. He also served as Director of FDA’s Over-the-Counter Drug Review. Mr. Yingling received his B.S. in Pharmacy from the University of North Carolina, an M.S. in Pharmacology from Purdue University, and his law degree from Emory University. He is counsel to the International Society for Regulatory Toxicology and Pharmacology, is Editor of the Guide to Good Clinical Practices, and serves on the Editorial Board of both the Clinical Research Practices and Drug Regulatory Affairs and Regulatory Toxicology and Pharmacology journals.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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