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.
Camille Diges, PhD, is the Global Director for Life Sciences at Unisys. She brings over 15 years of experience leading product and software development for the life sciences industry. She brings deep knowledge of product development for biotechnology and alliance management across the Life Sciences. She is leading the blockchain supply chain initiative for pharmaceuticals at Unisys.
Camille previously served as a Director of Data Science for Cognizant Technology Solutions where she led a team of data scientists delivering analytics across all verticals. She led her team in developing software products to improve pharmacovigilance techniques and drive high throughput data analysis for the pharmaceutical industry. Camille also drove delivery and fulfillment across Life Sciences for pharmaceutical, biotechnology, and medical device clients. Prior to this role, she was at Bio-Rad Laboratories where she worked across the corporation in business development, M&A, portfolio management, and R&D.
Camille was an American Cancer Society Post-Doctoral Research Fellow at Stanford University School of Medicine. She has a PhD, Biochemistry from the University of Colorado, Boulder and a BS in Chemistry from the University of Pittsburgh. She is a specialist in kinetics and biophysics and has published several peer-reviewed articles in this area.
Hazel Aranha is a biopharmaceutical industry professional with over 30 years’ experience in industry, academia and consulting. She is a well-acknowledged expert in the area of virus and prion clearance from biopharmaceuticals. She has provided consulting services in the US, Europe and Asia. She teaches courses on ‘ensuring virus safety of biologicals’, as well as other topics including: ‘Good Clinical Practices’ (GCP), ‘Good Manufacturing Practices (GMP), ‘Downstream Processing’, ‘Navigating the Drug Development Cycle’, and ‘Effective Biomedical Writing’.
Hazel has a Master’s degree in Virology, Ph.D. in Environmental Microbiology and holds Regulatory Affairs Certification (RAC) for both the US and European Union. She has to her credit 2 books, over 45 publications, and 5 book chapters. Her past assignments have included positions at Catalent Pharma Solutions, Wyeth Vaccines (Pfizer), and Pall Corporation.
Roger Muse is a Vice President at the ANSI-ASQ National Accreditation Board. ANAB is the largest accreditation body in the United States and is responsible for the accreditation of laboratories, inspection bodies and PT providers and others. ANAB also oversees and accredits certification bodies (who in turn provide certification such as ISO 9001, ISO 13485 and others).
Roger Muse primarily works with U.S. regulators and industry specifiers to design conformity assessment programs which address safety and reliability issues in their quality infrastructure. Roger has previously chaired a committee within the International Laboratory Accreditation Cooperation (ILAC) and currently serves on the U.S. ICAC committee which collaborates U.S. input and votes on all ISO standards. He has over 16 years in the accreditation and standards industries, a B.S. in Biochemistry and an MBA, Finance degree from the Johns Hopkins University.
Lucien (Luc) Sergile Jr. is a Quality Manager working for the Global Quality Auditing and Compliance Group at Eli Lilly and Company. In his 20 years of Monoclonal Anti-Body Production, Luc brings over 10 years (working for ImClone Systems and Eli Lilly) of experience in of GMP Biopharmaceutical Manufacturing and Validation. Luc was instrumental in the commissioning of two state of the art Biopharmaceutical production facilities for Eli Lilly in Branchburg, NJ.
For the last 11 years, Luc Sergile works with Corporate Quality Auditing for Lilly’s Global Quality Auditing and Compliance. Luc audits and monitors supply chain participants to support the global manufacturing of Lilly drug products and medical devices. Luc brings his expertise in GMP manufacturing and Supplier Oversight and knowledge to the table especially concerning data integrity when it comes to monitoring critical process parameters and ensuring the legitimacy and consistency of data with suppliers.
Luc also is a member of the IPEC Americas and Rx-360 and has helped author-auditing guides such as the IPEC GMP Audit Guide and the Rx-360 Data Integrity Audit Guide.
Vivian Berni, MPH, is a Senior Advisor at DHL’s Temperature Management Solutions. She consults and designs transportation solutions that enhance customer satisfaction and success in the Life Sciences and Healthcare sector.
Vivian has worked with the Life Sciences and Healthcare transportation industry since 2009, playing key roles at DHL in product development, corporate strategy and innovation through digital transformation. She is passionate about helping, educating and supporting clients as they develop strategic plans for the future. Currently, Vivian is implementing data-driven solutions that aid customers evolve their business.
Vivian earned her Masters of Public Health from the George Washington University and holds a Bachelor degree in International Finance and Marketing from the University of Miami. She attended the University of Economics and Business of Vienna to study innovation. Vivian served as Rx-360 Communications Chair. She has been published, participated in DHL Start-Up Lab, and constantly pursued her curiosity to learn.
Jim Henderson is a Business/Computer System QA for Eli Lilly and Company Global Quality Labs. Jim Henderson has 27+ of experience around QC Laboratories in multiple roles: analytical equipment qualification and validation, global consultant for data integrity and lab analytical equipment qualification and validation, and Business QA / Computer System QA. Jim has been deeply involved in data integrity improvement efforts for the past 7 years. He co-authored and delivered a global project to train QC Lab personnel in data process mapping, identifying and remediating data integrity risks. Jim co-authored the internal global standard on Laboratory Analytical Equipment Qualification and Software Validation. Jim co-authored the new Rx-360 GMP Audit Manual Data Governance and Data Integrity.
Mark Walker has over30 years of industry experience and is currently employed with Sartorius Corporation as Global Training Director for the Americas. The current curriculum ranges from technical and soft skills training for employees and clients, along with employee coaching/mentoring. Prior to Sartorius, Mark was instrumental in providing e-learning and simulation content to various biopharmaceutical companies. Mark served as the sales officer for a learning company which provided continuing medical education (CME) for physicians, nurses, and healthcare employees. During this time, the Learning Management System (LMS) contained more than 10,000 learning objects that describe and illustrate the medical biology underlying the major diseases ranging from Cardiovascular, Infectious Diseases, Oncology, and Central Nervous System along with an extensive library of regulatory and compliance courses.
Prior to the training arena, Mark worked with various Fortune 500 companies from sales to corporate management positions serving biotechnology and pharmaceutical manufacturers. During this tenure, Mark was involved in all phases of these operations ranging from R&D and Pilot Development to Final Fill and Finish. From his strong understanding of biology, biochemistry, genetics, engineering, and business, Mark personified consultative solution selling and is recognized as a significant contributor to improving various processes, and improving the clients Return On Investment (ROI).
Johannes Schoen is responsible for the global anti-counterfeiting program of Boehringer Ingelheim covering aspects of response, monitor and prevention.
He joined BI in 2000 to head a QC laboratory for packaging materials and devices and a team performing validation and transfers of packaging processes. This was followed by assignments in BI’s global operations network and global supply chain including performance management and benchmarking. Since February 2012 he is in his current responsibility within BI’s Corporate Quality Assurance Division with a strong involvement in the global implementation ofserialization and track & trace.
Before that Johannes gained experience in the consumer good industry managing packaging development and machinery projects as well as operations including a Total Productive Maintenance program achieving the Japan Institute of Plant Maintenance (JIPM) TPM Award in 1998.
Johannes is currently a member of the German Institute for Standardization (DIN) working group packaging and the European Federation of Pharmaceutical Industries and Associations (EFPIA) anti-counterfeiting work stream.
Johannes holds a degree of mechanical engineering from the Technical University of Munich, Germany. Since 2005 he is lecturing on packaging of pharmaceuticals at the University of Applied Sciences, Bingen, Germany.
Aura Stewart is the awarded Regional Councilor for Latin America at the ASQ Food, Drugs, and Cosmetics division and the lead of the Food Community of Excellence for the same group. Aura is a former member of US ISO TAG 176 committee on Quality Management, the working group responsible for revision of the ISO 9000 standards and represented US in the ISO CASCO Spanish Translation Task Force. As a professional, Aura offers extensive management, quality systems, regulatory compliance, food safety, quality assurance, social responsibility, and business consulting experience within a wide variety of organizations, from food and biotechnology to manufacturing and services. She is passionate about excellence, innovation, problem solving, and sustainability. Aura is currently working as independent consultant.
Jim Yarbrough leads BSI’s team of supply chain intelligence analysts and assesses the potential threat of criminal activity, terrorism, and cargo disruption to global supply chains.
Mr. Yarbrough also provides information and analysis about the threat to international cargo to governments around the world and to a number of Fortune 500 companies. He has also developed a unique study on acts of terrorism that specifically target supply chain infrastructure, personnel, and modes of transportation.
Mr. Yarbrough previously served as a Research Associate with the Center for International Trade & Security at the University of Georgia. There, he conducted on-site assessments and provided analysis on foreign export control and border security practices on behalf of the U.S. Department of State. Earlier in his career, Mr. Yarbrough served as an Import Manager for a multinational flooring company and has first-hand knowledge of international trade requirements.
Rosemary Gibson is Senior Advisor at The Hastings Center and principal author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine.
She is the 2014 recipient of the highest honor from the American Medical Writers Association for her contributions to the field of medical communication. Her writing gives voice to the public’s interest in critical health care issues of the day. She is author of Medicare Meltdown (2013), Battle Over Health Care (2012), Treatment Trap (2010), Wall of Silence (2003).
Rosemary is chair of the board of the Altarum Institute, a non-profit health systems research organization headquartered in Ann Arbor, Michigan.
She is a board member of the Accreditation Council for Graduate Medical Education and serves on the ACGME CLER Evaluation Committee which aims to engage resident physicians in improving quality and patient safety.
At Robert Wood Johnson Foundation, Rosemary was chief architect of its $250 million, decade-long national strategy to establish inpatient palliative care programs that now number 1600, an increase from about 10 in the 1990s. She received the Lifetime Achievement Award from the American Academy of Hospice and Palliative Medicine, and worked with Bill Moyers on the PBS documentary, “On Our Own Terms.”
While at the Foundation, Rosemary led national quality and patient safety initiatives in partnership with the Institute for Health Care Improvement: Pursuing Perfection, Transforming Care at the Bedside, and Rapid Response System Implementation. She is the recipient of the Lewis Blackman Patient Safety Award from the South Carolina Hospital Association.
Rosemary serves on the MedStar Health System Institute for Quality and Patient Safety Advisory Board in Washington, D.C., and is faculty for the Academy for Emerging Health Care Leaders, an annual summer safety immersion program for medical and nursing students and resident physicians.
Rosemary has given presentations and grand rounds at hundreds of hospitals; keynoted meetings of the National Quality Forum, The Joint Commission, National Board of Medical Examiners, American Academy of Otolaryngology, AONE, National Council of State Boards of Nursing, Federation of State Medical Boards, National Summit on Overuse held by The Joint Commission and AMA, Society of Critical Care Medicine, among others. She has been faculty for the Dartmouth Summer Symposium on Quality Improvement and was its 2013 “wizard.”
She has spoken to public audiences at the New York Public Library, the AARP National Convention, George Mason University; legislators at the National Council of State Legislators; Women’s National Democratic Club, Connecticut Center for Patient Safety, Maine Quality Counts, Maine Area Agencies on Aging, among others.
Her books have been reviewed in Publishers Weekly, Washington Post, JAMA, Health Affairs; referenced in proceedings of the U.S. Senate; mentioned in Congressional testimony; noted in the WSJ, NYT, USA Today, Consumer Reports, and Boston Globe, O Magazine, Reader’s Digest, US News and World Report. Wall of Silence was translated into Japanese; the Chinese translation of Treatment Trap won the prestigious Open Book Award from China Times. Rosemary has appeared on Chicago Tonight, WBGH’s Greater Boston, Fox News, The Doctors, C-Span Book TV.