Lead Quality Systems and Compliance Consultant, King and Spalding LLP
Steve Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure FDA compliance. Steve retired from the FDA in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as chief operating officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of ORA, including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Steve assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Steve served as the principle liaison to the CDRH, and was a member of the GHTF Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical cGMP for the 21st Century initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the director and deputy director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities. Steve currently participates as a member of the Medical Devices Committee at FDLI and as a member of the editorial review boards for FDAnews’ GMP publications.
David A. Borasky
Vice President of IRB Compliance, WIRB-Copernicus Group (WCG)
David A. Borasky Jr. serves as Vice President of IRB Compliance for the WIRB-Copernicus Group (WCG). In this role he is responsible for leading the quality and compliance activities for all of the WCG institutional review boards (IRBs). Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities on basic research ethics and IRB operations and management for IRB staff and members for institutions and IRBs throughout the US and abroad. He has served as a consultant for the Office for Human Research Protections, the US Department of Energy, the World Health Organization, and numerous other institutions. He currently serves as co-chair of the Subpart A Subcommittee of the DHHS Secretary’s Advisory Committee on Human Research Protections. Borasky is a Certified IRB Professional and former member of the board of directors of Public Responsibility in Medicine and Research (PRIM&R). In 2018 he was named a Distinguished Leader of PRIM&R. He received his undergraduate education at Le Moyne College and his master’s degree in public health leadership from the University of North Carolina at Chapel Hill.
Executive Director of Medical Device Education and Training, International MDSAP Team Lead, NSF Health Sciences
Robert (Rob) Ruff joined NSF International as the Executive Director of Medical Device Education and Training in December 2017. Rob has over 30 years of experience in the medical device and public health sectors. Prior to joining NSF International, Rob worked in the orthopedic device manufacturing industry and completed a long, distinguished career with the US FDA. Rob was a highly regarded district Medical Device Specialist and Senior Investigator in FDA’s Office of Regulatory Affairs (ORA), where he conducted investigations for a broad range of device technologies. During this time, he was a member of the ORA Medical Device Investigator Certification Board, where he co-developed ORA’s Level II medical device investigator certification program. From ORA, Rob was recruited by FDA’s Center for Devices and Radiological Health to lead an international team of subject matter experts tasked with the development, implementation, and maintenance of the Medical Device Single Audit Program (MDSAP). Rob’s in-depth knowledge of the MDSAP now serves as a valuable asset to NSF clients marketing products around the globe. Rob’s extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). Training has been a hallmark of Rob’s distinguished career, having developed FDA’s computer-based training for QSIT, the Quality System Regulation, and the Medical Device Reporting Regulation. Mr. Ruff received many awards for his honorable service with the FDA.
Fellow, Regulatory Compliance Associates, Inc.
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She is a member of the PDA Board of Directors, and has served as PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and chair of the PDA’s Regulatory Affairs / Quality Advisory Board. Sue was awarded PDA’s Distinguished Service Award in 2008.
PRECONFERENCE WORKSHOP LEADERS
Managing Director and Principal, Cerulean Associates LLC
John Avellanet is the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010, Logos Press), and founder of the FDA compliance consulting firm, Cerulean Associates LLC. Prior to founding Cerulean, John was a former Fortune 500 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, FDA, DEA, and HIPAA compliance. During his career, he had to defend decisions to inspectors, auditors, and litigators alike. John is also an expert member of the ISPE Data Integrity Working Group. He now brings that real-world experience and practical advice to his consulting clients, his articles, and his speeches.
Susan Leister, PhD
Vice-President of Quality & Compliance of Technical Resources International
Dr. Susan Leister, Vice-President of Quality & Compliance of Technical Resources International, boasts 20-plus years of industry experience and holds CQA and CSSBB certifications from American Society for Quality. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge. She has served as a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the past five years.
President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. Dan is now president of Ombu Enterprises LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Master’s degree in Mathematics; is an ASQ-certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and is certified by APICS in resource management.
Kalah Auchincloss, J.D.
Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
Kalah has more than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at FDA, most recently, as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
Senior Director, Quality Operations, Ethicon Wound Closure Repair (JnJ)
Maura has been at Johnson & Johnson for the past 6 years in various roles in Quality & Compliance leadership. For the past year she has held the position of Quality Operations Director for the Ethicon Wound Closure Business – leading quality for 12 worldwide suture, mesh and topical skin adhesive manufacturing sites (Raw Materials & Finished goods). Prior to the Quality Ops role, she has had responsibility for Regulatory Compliance for the Ethicon and the CSS group of companies including BWI, ASP, Mentor, Sterilmed and Acclarent. Upon joining J&J, Maura led compliance remediation program management for J&J. Prior to joining J&J in 2012, Maura worked for Wyeth Vaccines as Quality Head for the Polysaccharide manufacturing factory in Pearl River, NY as well as a role reporting to the plant manager infusing compliance into manufacturing operations. She also spent 5 years at Merck & Co. including an international assignment in Dublin, Ireland performing inspection readiness activities throughout Europe. She began her career as an FDA investigator in the NJ-DO and served as a Compliance Officer in the Center for Drug Evaluation and Research, Office of Compliance. Maura graduated from Villanova University with a degree in Biology and lives in Westwood, NJ with her husband, Kevin and 3 children.
Americas Program Manager, Medical Business Assurance, Intertek
Alexander Crosby is the Americas Program Manager for Medical Devices in Intertek’s Business Assurance group. and as such is responsible managing the program’s accreditations and recognitions and resources. Prior to joining Intertek more than eight years ago, Alexander worked and consulted for medical device, healthcare IT and consumer products companies for more than 15 years. Alexander holds an MBA from UVA’s Darden School of Business Administration, a Bachelor of Arts from Haverford College and a Graduate Certificate in Health Product Risk Management from Virginia Tech.
Deputy Director, Office of Bioresearch Monitoring Operations, OMPTO, ORA, FDA
David K. Glasgow is the acting director for the Bioresearch Monitoring Program within the ORA at the FDA. As the acting program director, Mr. Glasgow is responsible for working with counterparts from each of FDA’s six product centers in establishing a new, stand-alone Bioresearch Monitoring Program that includes all commodity areas. This work includes establishing a foundational training and development program, consistent and standardized processes across the program, and developing and implementing a complete governance system for the program. Mr. Glasgow’s permanent position is director, Division of Food and Feed Program Operations and Inspections. He has also been the director of the Investigations Branch in the Dallas District, a supervisory investigator in the Kansas City District, a bioresearch monitoring specialist in the Baltimore District, an investigator in the Denver District, a consumer safety inspector in the Los Angeles District. He began his career with FDA in 1987 as a clerk-typist in the Los Angeles District.
Consultant, FDA and Life Sciences, King & Spalding
Quynh Hoang is a Senior Regulatory Consultant in the FDA & Life Sciences practice group of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process (for medical devices and combination products containing device (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as, in the FDA’s postmarket process for adverse signals. Ms. Hoang joined King & Spalding after 24 years at the FDA’s Center for Devices and Radiological Health. Her experience at the FDA included 19 years in the premarket review of cardiac, ophthalmic and neurological devices, where she served as an Electrical Engineer Reviewer, Chief of the Vitreoretinal and Extraocular Devices Branch or Chief of the Neurodiagnostic and Neurosurgical Devices Branch. Highlights of her accomplishments include leading the review of the first ophthalmic excimer laser systems that are the precursors of todays’ LASIK Eye Lasers and receiving recognition as the FDA’s Peer-Reviewed Expert in Laser Refractive Surgical Devices. For the neurological device area, she was a key contributor to the review policies and to the reorganization in 2009 as well as the current structure of the Division of Neurological and Physical Medicine Devices. On the postmarket side, Ms. Hoang was an Expert Issue Manager tasked with leading teams of premarket, postmarket and communication experts in identifying the response options for the Center.
VP, Global Head, Regulatory Compliance and Quality Assurance, Covance
Cassandra Kennedy is the Global Head for Regulatory Compliance and Quality Assurance at Covance, Inc, a LabCorp company. Previously, she served as Senior Vice President for Global Quality Assurance at Quintiles (IQVIA). In this position, she was a member of the Enterprise Compliance Office and the Compliance Management Committee of Quintiles, responsible for leading Global Quality Assurance for Quintiles’ Clinical Research, Clinical Laboratories, Phase I Units, and Systems Compliance. Kennedy is Regulatory Affairs Certified (RAC) and certified as a Healthcare Compliance Professional with over 30 years of clinical research experience. She has led quality assurance units in both the pharmaceutical and Clinical Research Organization (CRO) environments. Cassandra was a founding member of the Quintiles Data Privacy Board (Council on Data Protection), and served as Vice-Chairman of the Ethics Board (Council on Research Ethics) at Quintiles. Ms. Kennedy represented Quintiles on the Association of Contract Research Organizations (ACRO) Ethics & Regulatory Compliance Committee, serving as the committee chair in 2009. Kennedy also served on the DIA Content Advisory Committee for Continued Educational Programs. In 2010, Quintiles formed a women leadership program at Quintiles (WIN – Women Inspired Network), with the vision of inspiring and developing strong women leaders in the biopharmaceutical industry. Ms. Kennedy was a founding member of the Advisory Board and currently serves as the WIN Board chair. Kennedy is on the NC Board of Directors for the non-profit organization Dress for Success which serves to promote the economic independence of disadvantaged women by providing professional attire, a network of support and the career development tools to help women thrive in work and in life.
President, Medical Consultants PA
Phillip was formerly the V.P. for the Medical Division at Quintiles' Clinical Research Unit (phase I CRU) since 1996, the year Quintiles acquired Innovex's CRU. He worked both as an administrative executive and as an "in the trench" Principal Investigator for the Phase I unit. His career in clinical research dates back to 1979, an era before GCP and formal CROs. He has experience in most all phases of clinical research and have had the honor of performing numerous FIH studies as the PI and have served as a Medical Monitor for Phase II projects very earlyhis my career.
Alex John London
Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy, Carnegie Mellon University
Alex John London is the Clara L. West Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy at Carnegie Mellon University. An elected Fellow of the Hastings Center, Professor London’s work focuses on ethical and policy issues surrounding the development and deployment of novel technologies in medicine, biotechnology and artificial intelligence, on methodological issues in theoretical and practical ethics, and on cross-national issues of justice and fairness. His papers have appeared in Mind, The Philosopher’s Imprint, Science, JAMA, The Lancet, The MBJ, PLoS Medicine, Statistics In Medicine, The Hastings Center Report, and numerous other journals and collections. He is also co-editor of Ethical Issues in Modern Medicine, one of the most widely used textbooks in medical ethics.
Executive Director, MDSAP Regulatory Certification, NSF Health Sciences
Brian Ludovico has over 20 years’ experience in medical quality systems and regulatory certification requirements. He is currently the Executive Director of the Medical Device Regulatory Certification Program at NSF International which includes the global Medical Device Single Audit Program (MDSAP). Mr. Ludovico represented the Auditing Organizations (AO) group during the development and implementation of the MDSAP and currently sits as the chair of the AO group that interfaces with the participating Regulatory Authorities. He is an active Board member of the American Society for Quality (ASQ) Biomedical Section New England Discussion Group (NEDG) and a member of RAPS (Regulatory Affairs Professionals Society) He was formerly with the Certification Body/Notified Body TUV Rheinland Group for 21 years, most recently as the certification manager of the Americas. In that capacity, he was also responsible for the global management of the Canadian Medical Devices Conformity Assessment System (CMDCAS) and the Medical Device Single Audit Program (MDSAP), and represented all Certification Bodies under CMDCAS as the Chair of the Health Canada-Registration Body Forum held with the Regulatory Authorities. He was active in issues concerning the Global Harmonization Task Force, the FDA AP (Accredited Persons) and Third Party Review Programs, and the PMAP (Pilot Multipurpose Audit Program) between the USA and Canada.
Vice President of Digital Innovation, Sparta Systems
Steve McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve has more than 25 years’ experience in the healthcare industry, and is a recognized leader in business transformations and large-scale strategic technology deployments maximizing key value drivers of Quality Systems, Supply Chain Systems and Product Lifecycle Management. A former VP of Johnson & Johnson Quality Systems, Steve led a team of over 280 employees, implementing complex systems and process transformations across the entire J&J enterprise, delivering multi-million-dollar value propositions and greatly increasing product safety and supply chain continuity.
Principal Consultant, PAREXEL Consulting
Anita R. Michael, is a Principal Consultant at PAREXEL International, LLC and has more than 20 years direct experience in GMP requirements, quality systems, commercial manufacturing, pharmaceutical research, development and global pharmaceutical regulatory expertise. She is versed in 21 CFR 210, 21 CFR 211, Part 11, 21 CFR 4.1, 21 CFR 820 and device QSR (cross labeled, co-packaged and single entity). Ms. Michael has 16 years direct experience with the US FDA operating as a Pharmaceutical Expert (Specialist) for FDA Inspections. She has conducted numerous Pre-Approval Inspections, Post Approval Inspections, Pre-Market Approvals, Data Integrity, Validation and cGMP Inspections both domestically and internationally specializing in biopharmaceuticals, sterile dosage forms, device drug combinations, aseptic processing, solid dosage forms, solutions, and APIs. Ms. Michael previously worked for one of the largest Global Pharmaceutical Company’s in Regulatory Affairs for Vaccines as a Global Regulatory Submission Specialist. Ms. Michael has received numerous outstanding awards and recognition throughout her career. Ms. Michael has a B.S. in Biology Minor in Sociology and Chemistry, graduated Magna Cum Laude from Temple University and has studied as a Medical Student at MCP Hahnemann School of Medicine in Pennsylvania.
Associate Commissioner, OMPTO,ORA, FDA
Ms. Morrison is the assistant commissioner for medical products and tobacco operations in the Office of Regulatory Affairs at the FDA leading a team that serves as focal point for coordination and management of ORA’s medical product and tobacco field activities. In 2002, FDA named Ms. Morrison the Director of Emergency Operations, Office of Crisis Management, where she directed and coordinated FDA’s emergency preparedness and response activities with federal, state, local, and international agencies, becoming the first Director of the Office of Crisis Management in 2003. She returned to ORA first as acting in 2012 and then officially in 2013, as the Assistant Commissioner for Operations. In 2017, she took on the role of Assistant Commissioner for Medical Products and Tobacco Operations for ORA, providing leadership for and management of the program directors for biological products, bioresearch monitoring, medical devices and radiological health, and pharmaceutical quality operations.
Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson
Susan Neadle is Sr. Director, Global Value Chain Quality Design at Johnson & Johnson. In this role, among her responsibilities Susan serves as head of the J&J Combination Products Community of Practice. Prior to this role, Susan was a member of the Product Quality Leadership Team at Janssen Pharmaceutical Companies of Johnson & Johnson. Her global responsibilities there included leading J&J’s Pharmaceutical Sector Combination Products Center of Excellence. Among several achievements during her tenure at Janssen, Susan led the team that defined and implemented the business model, integrating global cross-functional requirements, to meet Combination Products health authority regulations. This included ensuring inspection readiness, and actively participating in combination products regulatory and health authority inspections. Susan is a Design & Process Excellence Black Belt. Over her extensive career, she has successfully applied that competence while playing integral leadership roles in the product and process development of several new products. Based on the positive impacts of her work, Susan was awarded The Johnson Medal for Research & Development, the highest innovation award given at Johnson & Johnson. She holds numerous patents and publications. Susan earned an M.S. in Polymer Science & Engineering, and a B.S. in Biology & Chemistry, as well as Fellowship in the American Academy of Optometry. Prior to joining Johnson & Johnson, she held R&D and Commercialization positions at Unilever, Organon Teknika and IBM. In these positions, she worked in controlled release technology, medical diagnostics, and materials analysis.
Director, Xavier Health, Xavier University
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries. These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries. Phillips aligns the mission of Xavier Health with the Strategic Priorities of the FDA. Phillips is the founder and co-chair of the FDA/Xavier University Medical Device Conference; founder and co-chair of the FDA/Xavier University PharmaLink Conference; founder and chair of the Integrity of Supply Initiative for the food, drug and device industries; and founder and chair of the Board of Directors for the QA/RA Institute of Xavier University. Additionally, Phillips serves as a consultant and expert witness to the pharmaceutical industry. Phillips started in the industry in 1996 when she was employed by Merck & Co., where she quickly took on positions of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility in 2000.
Marc J. Scheineson
Partner, Alston & Bird LLP
Marc J. Scheineson is a Partner in the Washington, DC office of Alston & Bird. He heads the firm’s food and drug law practice. Marc previously served as Associate Commissioner for Legislative Affairs at the FDA. He came to Washington, D.C. to work as Legislative Assistant and Counsel to Rep. Bill Gradison (R-OH), the ranking member of the Health Subcommittee of the House Ways and Means Committee. In addition, he worked as a regulatory FDA lawyer for another national law firm, and Senior Vice President of Ketchum Communications and as a Principal in its government relations unit. Mr. Scheineson is a former Co-Chairman of the American Bar Association’s Committee on Food and Drug Law; chaired the Task Force on FDA Reform and is a former Chair of the Young Lawyers Section of the Bar Association of the District of Columbia. He received his B.A. and J.D. from the University of Cincinnati and its College of Law and his L.L.M. from the Georgetown University Law Center.
Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
With more than 25 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Executive Vice President, Regulatory Compliance. Cynthia was formerly Director of the Office of Compliance for FDA’s CDER, where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues. Before joining FDA in 2014, Cynthia spent more than two decades at the DOJ, where she specialized in compliance and enforcement issues. Her most recent position at DOJ was as Deputy Inspector General and Acting Inspector General, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent audits of the Department’s operations and programs. She communicated significant findings from the investigations and reviews to the Attorney General and to Congress. Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U. S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division. Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas. Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Quality Director, IDM, Eli Lilly and Company
David Shore is currently Site Quality Leader for Indianapolis Device Manufacturing for Eli Lilly and Company. Prior to joining Lilly, David held various positions in Validation, Operations and Quality at Pfizer supporting Pharmaceutical Production. David joined Lilly 15 years ago and has spent the last 12 years in the medical device Quality organization supporting site production and global supply of medical device components and subassemblies. David has 20+ years of pharmaceuticals and medical device experience and has served as a host for regulatory inspections throughout his career. David received his B.S. in chemical engineering from Rose Hulman Institute of Technology.
Executive Director, Metrics Champion Consortium
Ms. Sullivan is Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms. Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.
Corporate Vice President, PAREXEL Consulting
Dr. Tetzlaff is currently Corporate Vice President, PAREXEL International LLC. His 50+ years of experience includes 27 years as an Investigator with the FDA, and during the past 25 years with PAREXEL he has provided GMP compliance and quality system services to companies located throughout the world. He received B.A. in Zoology from the University of Washington, Seattle and M.S. and Doctor of Philosophy degrees in Pharmaceutics from the University of Georgia, Athens. Dr. Tetzlaff is a member of PDA and FDLI, and is active in industry programs on quality management, GMP compliance, and data integrity related issues, having made more than 300 presentations at various national/international industry symposia and FDA training programs, and he has published more than two dozen articles and several chapters in textbooks. He is currently a member of PDA Task Force on Data Integrity, and for past 20+ years has served a member of the Conference Advisory Committee for the UGA International GMP Conference.
Vice President Manufacturing Quality, Cardinal Health
Karl Vahey is currently the Vice President Manufacturing Quality with Medtronic. Karl has 25 years of experience in the medical device industry and has worked in manufacturing, quality assurance, regulatory affairs and quality systems compliance. His current responsibilities include overseeing quality operations and quality compliance for 16 manufacturing facilities in North and South America and Europe. Prior to this Karl was Senior Director of Regulatory Compliance, Covidien. This role included the following responsibilities: quality compliance activities such as conducting audits, development of best practices and providing general support as appropriate to Covidien facilities (manufacturing, distribution centers and technical service centers) and third-party suppliers in EMEA, Latin America and Asia Pacific. Karl was also heavily involved in the development of corporate quality system training programs such as process validation, CAPA, internal audits, change management and the implementation of these corporate training programs to all international sites.
Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA
Marc-Henri Winter is Assessment Program Manager for the Medical Device Single Audit Program. He is a biomedical engineer and has been working since 1998 as assessor of medical devices and auditor of quality management system according to international medical device regulations, including in particular the European and Canadian and US regulations. He joined the U.S. Food and Drug Administration in 2012 to support the development and the implementation of the Medical Device Single Audit Program, a cooperative program initiated by the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), Health Canada, and the US FDA, and based on the foundations established by the International Medical Device Regulatory Forum (IMDRF).