King of Prussia, PA (PRWEB) December 10, 2013
Tunnell Consulting, Inc. today announced that Anthony A. Charity, who served in the U.S. Food and Drug Administration (FDA) for more than twenty years, has joined the firm as a Managing Consultant, Quality and Compliance.
“Anthony Charity’s experience at the FDA enables him to provide our life sciences clients with invaluable help in understanding good manufacturing practices, preparing for inspections, and mitigating compliance risks,” said Philippe Cini, Ph.D., Group Vice President. “His expertise complements Tunnell’s longstanding strengths in quality and compliance, areas in which excellence is absolutely critical for pharmaceutical companies.”
Prior to joining Tunnell, Mr. Charity served as FDA Branch Chief for the Dedicated Drug Cadre Division of Medical Products and Tobacco Inspection, Rockville, MD, where he supervised drug investigators who inspected the foreign manufacturing operations of firms who market pharmaceutical products in the U.S.
“I am delighted to join Tunnell’s Quality and Compliance practice, with its long track record of success, its exclusive focus on the pharmaceutical industry, and its proven methodologies for addressing quality and compliance,” said Mr. Charity. “In a regulatory environment that is becoming increasingly science-driven, the firm offers to clients a breadth and depth of resources that is hard to match.”
Prior to his role as a Branch Chief, Mr. Charity served as a Compliance Officer for the FDA’s Center for Drug Evaluation and Research (CDER), Division of Manufacturing and Product Quality. At CDER, he reviewed proposed regulatory actions for conclusiveness and acceptability of evidence; nature and extent of deviations from current good manufacturing practices (cGMPs), and appropriate regulatory action strategy. He is expert at identifying and evaluating cGMP problems in the manufacture and control of active pharmaceutical ingredients (APIs) and intermediates and their impact on the quality of finished pharmaceuticals.
He also authored the “Active Pharmaceutical Ingredient Process Inspection Compliance Program Guidance Manual 7356.002F,” a comprehensive cGMP inspection guide for determining whether a manufacturer of APIs is operating in a state of control.
He began his career with the FDA as the Consumer Safety Officer, U.S. Custom House, Philadelphia, PA, where he conducted inspections in industries that were regulated by the FDA, primarily in the pharmaceutical, bioresearch monitoring and good laboratory practices areas.
Mr. Charity received his B.A. in Chemistry from Cheyney State University, Cheyney, PA.
About Tunnell Consulting
Founded in 1962 and serving many of the world’s leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical, process, and organizational skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve.