Bill O'Connell is a Senior Quality Systems Expert with the firm’s FDA & Life Sciences Practice Group in Washington, D.C.
Mr. O’Connell has more than 33 years of experience in Food and Drug matters, including nineteen years with the FDA. In addition, he spent fourteen years as a consultant to the pharmaceutical, biologic and medical device industries for a large internationally known consulting firm. Mr. O’Connell is nationally recognized for his knowledge of the application and interpretation of the CGMPs/QSR regulations for drugs, biologics and medical devices, and he is recognized as a national and international leader in the areas of equipment qualification, process validation, design controls and product and process risk assessment practices.
While at the FDA, Mr. O'Connell served as the Associate Director of the Division of Enforcement II, Office of Compliance of the Center for Devices and Radiological Health (“CDRH”). He was Section Chief of the Office of Compliance and Surveillance of the Manufacturing Quality Assurance Branch from 1991 to 1993. From 1989 to 1991, Mr. O’Connell was with the Generic Drug Compliance Branch of the Center for Drug Evaluation and Research, Office of Compliance. While in this position, he was assigned to the U.S. Attorney’s Office in Baltimore, Maryland as a GMP and Drug Manufacturing Process Expert and led several Grand Jury investigations into the Generic Drug Industry. From 1987 to 1989, Mr. O'Connell served as a National Expert for Medical Devices and Sterilization Processes in the Office of Regulatory Affairs where he was a Recognized Expert in sterile processes and aseptic processing of drug, biological, medical device and IVD products.
Mr. O'Connell is a graduate of the American University where he studied Biology, Chemistry, and Psychology. Mr. O’Connell is a member of the Association for the Advancement of Medical Instrumentation, the American Society for Quality, and the International Standards Organization (ISO TC 198, Sterilization of Healthcare Products; ISO TC 209, Design and Operation of Clean Rooms; and ISO TC 210, Medical Devices).
