Committee & Speaker Biographies

Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Mr. Cosgrove brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.

At FDA, Mr. Cosgrove held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. As Acting Director of CDER Compliance in 2016, Mr. Cosgrove oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.

Tracy has been a GMP Inspector since 2011 and prior to joining the MHRA worked in the pharmaceutical industry for 22 years working across most dosage forms within Quality and technical roles. Her experience ranges from starting as a QC analyst to holding senior managerial and technical positions and she is an eligible Qualified Person in the UK. Tracy is currently lead of the MHRA Inspectorate Technology team responsible for providing guidance and strategy for new and emerging technologies and data integrity. To assist in MHRA pandemic efforts, Tracy is currently also participating in the MHRA Task Force for supply chain aspects.  Tracy is the deputy of the PIC/S Strategy and Development Sub Committee and leads specific PIC/S working groups.

Mark Newton is a Pharmaceutical Quality professional with 37 years of experience in data integrity, LIMS, validation of computer systems, analytical systems, risk management, and quality systems, especially in the regulated laboratory space. He held roles in QC Labs, Computer Systems QA, Laboratory Informatics and QA during his 34-year tenure at Eli Lilly and Company. As an independent consultant since retiring from Lilly in 2018, He has assisted firms with forensic data reviews, good documentation practices, risk evaluation and process mapping to identify data integrity gaps and improve quality systems.

Mark has also been actively involved in ISPE/GAMP publications for a decade, co-editing to the GAMP Good Practice Guide for Computerized Laboratory Systems (2012) and writing for Records and Data Integrity Guide (2017) and Data Integrity-Key Concepts Good Practice Guide (2018) and GPG: Data Integrity by Design (2020) . He has also co-written articles with Robert McDowall on data integrity topics that have appeared in LC/GC Magazine.

Anne V. Renton is a Research Scientist in the Technical Service Manufacturing Science Organization at Eli Lilly and Company.  She previously worked in Quality Assurance and has been at Eli Lilly since 2002. She had over fifteen years’ experience in quality and manufacturing prior to joining Lilly. Her experience includes; quality risk management, six sigma initiatives, implementing lean manufacturing, optimizing manufacturing processes and quality system implementation.  Anne holds a Bachelor of Science degree from Indiana University and an M.B.A. from Indiana Wesleyan University.