Anne Kelly is a Senior Good Manufacturing Practices Expert with the firm’s FDA & Life Sciences Practice Group in Washington, D.C.
With more than 25 years of experience in food and drug matters, including more than seven years with the FDA, Ms. Kelly specializes in working with firms to resolve complex compliance issues and assists clients to successfully communicate results and achievements to FDA. Ms. Kelly’s expertise spans biologic drugs, pharmaceuticals, biologic devices and medical devices.
Ms. Kelly is recognized for her knowledge, application, and interpretation of the current Good Manufacturing Practices/ Quality System Regulation (CGMPs/QSR) regulations for pharmaceutical, biologic products and medical devices including invitro diagnostics. She is an expert in the areas of quality systems, laboratory operations, and preparing sites to host and manage FDA inspections. She specializes in design of non-conformance management systems; investigation of manufacturing deviations; handling of out of specification laboratory investigations; complaint handling, corrective and preventative action systems, design and implementation of change control programs; and conducting mock pre-approval audits and verification audits to prepare sites anticipating FDA inspection. Ms. Kelly excels in preparing responsive communications to FDA for FDA-483s, Warning Letters, corrective action plans, improvement plans and independent audits reports. Prior to joining King & Spalding, she was the Senior Vice President of Quality for a generic pharmaceutical company; a compliance consultant to pharmaceutical, biologic and medical device industries with increasing roles of responsibility for eight years; and worked as a medical technologist at several clinical hospital laboratories for five years.
While at the FDA, Ms. Kelly served as an Investigator, the Midwest Regional Non-Sterile Drug Expert, and as the Biologics Specialist in the U.S. Food and Drug Administration, Chicago District Office, Chicago, IL. She conducted inspections of pharmaceutical, medical device firms and blood banks with emphasis on the manufacturing operations, non-conformance systems (reworks, rejects, complaints, deviations) and laboratory operations. Her inspections focused on routes of possible cross-contamination (chemical or microbial) and sterility assurance. She specialized in inspections of high purity water systems, process validation and laboratory testing especially “retesting.” She conducted domestic and foreign inspections including active pharmaceutical ingredient (API), finished drug, fractionators, blood banks, medical device companies and contract laboratories. She developed evidence used in FDA actions including Warning Letters, seizures and consent decrees.
Ms. Kelly obtained her Bachelor of Science in Medical Laboratory Science from the University of Illinois, College of Associated Health Professions in Chicago, Illinois and then worked as Medical Technologist in several laboratories - microbiology, immunology, virology and serology. She was certified by the American Society of Clinical Pathologists as a Medical Technologist, and by the National Certification Agency as a Clinical Laboratory Scientist.
Professional Certifications (1985)
- Medical Technologist- American Society of Clinical Pathology
- Clinical Laboratory Scientist- National Certification Agency
