William J. Troy joined ASQ in 2014 following a 38-year U.S. Army career, from which he retired as Lieutenant General (three stars). His most recent position was director of U.S. Army Staff at the Pentagon. Troy served in Europe, the United States, Asia, and the Middle East. At ASQ, Troy directs the organization’s mission to advance quality and quality tools worldwide. His duties include ensuring the alignment of the strategies and goals established by ASQ’s board of directors. He also works with ASQ’s volunteer member leaders and represents ASQ as a board member of the ANSI-ASQ National Accreditation Board, Exemplar Global, and the Baldridge Foundation.
- Troy was director of the U.S. Army Staff from August 2010 until July 2013. He led 20,000 military staff and civilians, assisted in the oversight of a $5 billion budget, and ensured the integration and coordination of policies, plans, and decisions affecting the entire U.S. Army.
- Prior to his tour as director, he served as the Commanding General, U.S. Army Alaska, where he was responsible for the combat readiness of 12,000 soldiers, and the welfare of 20,000 family members.
- He has held a number of significant general officer positions on behalf of the U.S. military, including Chief of Staff for III Corps in Iraq during Operation Iraqi Freedom.
- Troy was commissioned in the infantry from the United States Military Academy, where he received a bachelor’s of science degree. He received master’s degrees from the Naval Postgraduate School, and the Naval War College, and was a Senior Fellow at Harvard University’s Weatherhead Center for International Affairs.
- He is the recipient of numerous awards, including the Bronze Star, the Combat Infantryman Badge, the Ranger Tab, Master Parachute Wings, the Distinguished Service Medal, and Commander in the French National Order of Merit.
Alan G. Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia andWashington, D.C. Prior to his association with AGG, he worked with a Washington, D.C. food and drug law firm. Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement,
FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. He serves on the Editorial Advisory Boards of the RAPS Focus magazine, the Center for Communication Compliance, and the Law Journal Newsletters’ Product Liability Law & Strategy journals and serves on the University of Georgia College of Pharmacy Regulatory Affairs Advisory Board. Mr. Minsk was recently selected as Chambers USA: America’s Leading Lawyers in Life Sciences: Regulatory/Compliance and was selected for inclusion in the International Who’sWho of Life Sciences Lawyers 2013 and 2014. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. He serves on the Board of GaBio, the PDMA
Alliance (as the General Counsel), and the Atlanta Jewish Academy. He is the former Georgia Chapter Leader of the Regulatory Affairs Professionals Society, and is also a member of the Food and Drug Law Institute, Conexx: America Israel Business Connector and serves on the External Advisory Board of the Atlantic Pediatric Device Consortium (APDC). He is a graduate of Brandeis University and Georgetown University Law Center.
Judith Svarczkopf is a Principal Technical Advisor at Genentech, with over 20 years of experience in the pharmaceutical and blood bank industries, working on combination products with medical devices and in-vitro diagnostics. She has extensive project management, quality system, and product design, development and launch experience and has worked on biologics administered subcutaneously using pre-filled syringes/auto-injectors; blood banking reagents; manufacturing-line improvements. Judith is currently the Lead for implementing device requirements into the global Roche/Genentech Pharmaceutical Quality System. She holds a Master of Science in Engineering from Purdue University, a Bachelor of Science in chemical engineering from Rutgers University, and a Master of Science in child development from the University of Tennessee.
Dr. Jose (Pepe) Rodriguez-Perez is the president and CEO of Business Excellence Consulting (BEC), a Puerto Rico consultant, training, auditing, and remediation firm in the areas of regulatory compliance, risk management, and operational excellence in the FDA-regulated sector. He’s also co-president of BEC Spain.
Pepe is a biologist and earn his doctoral degree in Immunology from the University of Granada (Spain). He has over 25 years of experience. He served as professor and director of the Microbiology Dept at one of the Puerto Rico school of medicine. He also served as Technical Services manager at a manufacturing plant of Abbott Laboratories in Puerto Rico.
From 2003 to 2012, he was professor for graduate studies of the Polytechnic University of Puerto Rico. During the period of 2009 to 2011 he served as a Science Advisor for the U.S. FDA San Juan District.
He is certified by the American Society of Quality (ASQ) as Quality Manager, Quality Engineer, Quality Auditor, Quality HACCP Auditor, Biomedical Auditor, Six Sigma Black Belt, and GMP Professional.
He served as a senior member of the ASQ and president of the Puerto Rico section from 2003 to 2005. He was its secretary from 2005-2012. He is also a member of the RAPS, AAMI, and the PDA organizations.
He is a frequent lecturer on issues of quality and regulatory compliance in Puerto Rico, USA, Dominican Republic, Spain, Mexico, etc. He has written several articles for Quality Progress (USA) and Quality Focus (Canada).
He’s the author of fiver best-selling books published by ASQ-Quality Press:
- CAPA FOR THE FDA REGULATED INDUSTRY (2010)
- QUALITY RISK MANAGEMENT IN THE FDA REGULATED INDUSTRY (2012)
- THE FDA AND WORLDWIDE CURRENT GOOD MANUFACTURING PRACTICES AND QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR FINISHED PHARMACEUTICALS (2014)
- HANDBOOK OF INVESTIGATION AND EFFECTIVE CAPA SYSTEMS (2016)
- QUALITY RISK MANAGEMENT IN THE FDA REGULATED INDUSTRY, Second Edition (2017)
Stephen McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve is uniquely qualified to enhance Sparta’s mission of advancing the value of Quality Management Systems for our customers. He has a key responsibility to aid our customers successfully transition to digital technology when they are ready. Steve serves as a key resource across the company, sharing his leadership, innovation and experience while contributing to customer interactions, marketing activities, industry leadership events and product development. In this role Steve supports Sparta’s mission of helping the industries we serve create higher quality, safer products, streamline their operations, lower risk and assure compliance, using innovative cloud solutions that support an all-digital strategy.
Stephen has nearly three decades of experience within the healthcare industry. Prior to joining Sparta, he held several high-profile positions within Johnson & Johnson (J&J), the most recent of which was as VP of Quality Systems Shared Services for all three segments of the company (Pharmaceuticals, Medical Devices and Consumer). There he led a team of over 280 employees, implementing complex systems and quality process transformations across the enterprise, delivering multimillion-dollar value propositions, and greatly increasing product safety and supply chain continuity. His earlier career was spent in virology research at the University Hospital St. Thomas’ in London.
Stephen holds a BSc in Medical & Industrial Biology from Cardiff University in Wales, UK.
Nancy Singer, JD, LLM, RAC, FRAP is an Assistant Professor at George Washington University’s School of Medicine and Health Sciences. She specializes in the professional development for government and industry professionals. She presently teaches good documentation practices to the investigators and compliance officers in FDA District Offices and the reviewers in FDA Staff Colleges. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently, she was a partner at the law firm of Kleinfeld Kaplan and Becker. During her career, she was the Executive Director of the Food and Drug Law Institute and General Counsel for Lansinoh Laboratories.
Nancy received her BS degree from Cornell University and her JD and LLM degrees from New York University Law School. She served in the Navy Reserve for 21 years and presently is a retired commander.
Thomas E. Menighan is executive vice president and chief executive officer of the American Pharmacists Association (APhA) and serves the APhA volunteer leadership and the pharmacy profession as EVP and CEO of the oldest and largest pharmacists’ organization in America. The organization promotes consumer access and coverage for pharmacists’ quality patient care services through advocacy, education and the provision of information that improve medication use and advance patient care. The International Pharmaceutical Federation (FIP) recently elected Menighan to its board as a FIP Bureau Vice President. He holds a number of board and leadership positions in broad pharmacy organization collaborations.
Menighan holds a Bachelor of Science in Pharmacy (BSPharm) and Honorary Doctor of Science (ScD) from West Virginia University, a Master of Business Administration (MBA) from Averett College and an ScD from the University of Charleston, WV. Menighan is a Fellow of the American Pharmacists Association (FAPhA).
Throughout his career, Menighan has served volunteer roles within the profession of pharmacy, including the elected President of APhA from 2001 to 2002 and a member of the APhA Board of Trustees between 1995 and 2003. He was a senior staff member of APhA from 1987 to 1992. While on staff as senior director of external affairs, he managed state affairs, public relations, new business development, and practice management issues.
Prior to his current leadership roles at APhA, Menighan was founder and president of SynTegra Solutions, Inc., in Germantown, Maryland. The company provided supply chain integrity and chargeback auditing for 12 major pharma companies and consulting in risk management, 340B systems, anti-counterfeiting, and the technology of medication information. Menighan also founded SymRx, Inc., and developed CornerDrugstore.com.
His other professional experiences include management of the PharMark Corporation, creator of RationalMed, and licensor of systems for states to conduct drug utilization review for millions of state Medicaid enrollees. Menighan also founded and was a 20-year Medicine Shoppe owner in Huntington, West Virginia, and he is a current partner in Pharmacy Associates, Inc., a multistate specialty pharmacy that today serves patients in much of the United States.
Extensive information about APhA can be found at www.pharmacist.com and www.pharmacylibrary.com. APhA provides education in many forms for pharmacists and technicians across the continuum from basic CE courses to advanced specialty training. Materials include books and periodicals, in both print and electronic forms. APhA advocates on behalf of pharmacists with Congress, Federal agencies, states through state pharmacy associations and with private organizations. Pharmacists gain extensive leadership experience through active participation in the organization and are recognized through the most extensive awards programs in pharmacy.