An exciting list of senior FDA and Industry speakers will participate in this year’s conference. More information on this year’s speakers to come!
2016 speakers included:
Ms. Ruth Dixon graduated from Saint Mary-of-the Woods College with a Bachelor of Science degree May, 1987. Ms. Dixon began her career with the Food and Drug Administration December, 1987 as a Chemist with the Los Angeles District Laboratory primarily working with the Pesticide Analytical Team. She later became a Consumer Safety Officer and Pesticide Coordinator in Los Angeles District (LOS-DO) December, 1995, and conducted a number of foreign and domestic farm inspections routinely related to microbiological outbreaks. In 1996 she became a Compliance Officer in LOS-DO, whereby she accomplished import and domestic compliance case work.
In October, 2008 Ruth joined New Orleans District by accepting a Supervisory Consumer Safety Officer position in Memphis, TN. December, 2011 Ruth accepted the position of Director of Import Operations and Compliance Branch, New Orleans District (NOL-DO), and then transitioned into the Director of Compliance Branch in 2013 to continue managing domestic and import compliance staff in NOL-DO. In November, 2014 Ms. Dixon became the District Director for New Orleans District and continues to look forward to many more amazing experiences with FDA as well as working with Other Government Agencies, State Governments, Academia and Industry to maintain and ensure the safety of public health.
Jessica Zeller is the ORA Ombudsman at the Food and Drug Administration, and has held this position since its inception in 2015. She is responsible for informally addressing concerns, complaints, and disputes arising between ORA and external parties, including industry, government entities (federal, state, territory, and tribal), and other members of the public. Ms. Zeller began her career at FDA in 2004 as a litigation attorney in the Office of Chief Counsel and subsequently was the Deputy Director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products. Before returning to FDA as ORA Ombudsman, Ms. Zeller spent 2 years as lead FDA attorney for Procter and Gamble. She holds a B.S.U.S. (biology) from Xavier University, and J.D. and M.A. (bioethics) degrees from the University of Virginia.
Angela Cushman is a leader in the medical device industry with over 20 years of experience. She is the Director of Global Post-Market Surveillance at Halyard Health in Alpharetta, GA. She has been with Halyard, formerly known as Kimberly Clark Health Care, for nearly 5 years. Prior to that, she spent 15 years with C.R. Bard, Inc. in their medical division.
Angela is a proven leader with strong analytical and problem solving skills. Throughout her career, she has launched over 50 new products within numerous new technology platforms in the areas of infection control, urology, airway management, bowel management, wound care, and wound drainage. She has worked in all phases of the product life cycle from concept development to currently working in the area of post market surveillance. . Voice of customer is the key to any product’s success!
Angela holds an MBA from Georgia State University and a Bachelor of Science in Chemical Engineering from the University of Maine (Go Black Bears!). She is also certified as a Quality Auditor and Quality Engineer from the American Society of Quality. Angela has extensive experience in the areas of product development, design control, manufacturing, validation, complaint handling, and post-market surveillance. She enjoys traveling with her husband and three children, reading, and shopping!
Alan G. Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia and Washington, 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’s Who 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.
Steve Holcroft has been with Johnson & Johnson for 20 years and is currently responsible for Combination Products Regulatory Compliance for the Johnson & Johnson Enterprise (Corporate). Steve has held various roles over his 20 year career at Johnson & Johnson which have included positions in Regulatory Affairs, Quality Assurance, Regulatory Compliance, Quality Control, and Research & Development across Johnson & Johnson’s Pharmaceutical, Active Pharmaceutical Ingredient (API), Consumer, and Medical Device segments. He has been involved with Combination Products throughout his career at Johnson & Johnson. Steve holds a B.S. in Biochemistry from Elizabethtown College. He and his family currently live in Jacksonville, Florida.
Dr. Ibim Tariah is the Technical Director for BSI Healthcare. He earned his PhD in Materials Science with emphasis on polymer science and technology from the University of Manchester, U.K.
Dr. Tariah has over 24 years experience in the medical device industry in which he led global organizations in successful product development, project management and provided technical expertise in support of commercial efforts. In the years, since coming to BSI, Dr. Tariah has been providing expertise in vascular, orthopaedic & dental and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Directive (MDD) and development & delivery of specialized MDD training courses.
His vast experience includes Regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics along with Quality Assessment of Medical Devices. He also acts as a liaison with Regulatory Authorities including MHRA (UK), European Medicines Agency (EMA), Medical Products Agency (Sweden).
Frances C. Akelewicz is president and principal consultant for Practical Solutions. Ms. Akelewicz has spent her 25+ year career in both the global pharmaceutical and medical device industries. She has extensive global experience including past participation in AAMI subcommittees and FDA working groups. The scope of business for Practical Solutions includes hands-on activities for organizations throughout the United States, Canada, Europe and the Middle East on Regulatory, Quality Management, Quality Engineering, CAPA, Process Validation and Clinical Study management. Ms. Akelewicz has participated in submissions for the pharmaceutical and device industries which included ANDA, NDA, PMA, and 510k. Additionally, she has managed major product launches, facility qualification and crisis management projects, development of a comprehensive quality program for R&D and development of a global clinical quality system. Ms. Akelewicz holds a M.S. in Quality Management, an MBA and a B.S. in Biology. Additionally, she holds national certifications in Quality Engineering, Quality Auditing, Quality Management. Ms. Akelewicz is currently a member of the graduate faculty with The University of Georgia’s MS in Regulatory Affairs and certifications programs in Clinical Trials and Regulatory Affairs.
Mullis is the Director of the College’s BioPharma Regulatory Affairs Graduate Education programs, a position that he has held since inception of the graduate program in 2004. He provided the expertise and leadership in developing the program’s curriculum and in recruiting professionals to teach in the graduate program. He also holds the rank of associate professor in the College’s, Department of Pharmaceutical and Biomedical Sciences. Mullis was a member of College’s external advisory committee that was instrumental in establishing the strategic plan to develop a graduate program in regulatory affairs that would meet the needs of Georgia-based life sciences, pharma and medical
Mullis is President of Mullis & Associates, Inc., a consulting firm that provides regulatory affairs and clinical studies support services for pharma, biotech, medical device and animal health companies. He has served as a principal consultant since the company was established in 1999. The firm has clients that range from startup ventures to Fortune 500 medical device firms and large pharmaceutical companies.
Mullis has more than 25 years of successful senior management experience working in the Food and Drug Administration (FDA)-regulated health care industry. He held leadership positions directing regulatory affairs and clinical programs with Eli Lilly/CPI, Inc., C.R. Bard, Inc., and London International Group, plc. He has extensive experience filing IDEs, INDs, 510(k)s, PMAs, and other marketing applications with FDA and international regulatory agencies. Mullis has assisted numerous companies with resolving Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and other regulatory compliance issues with FDA.