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!
Wilfredo Ruiz-Caban joined CONMED as Executive Vice President, Quality Assurance & Regulatory Affairs on September 8, 2015. In April, 2016, Wilf was given additional responsibility for Manufacturing and Supply Chain Operations of the Corporation. Prior to CONMED, held the position of Director, Americas Global Orthopaedics Manufacturing and Global Quality Operations Director at DePuy Synthes Americas, a Johnson and Johnson company. From 2009 through 2012, served as Senior Manufacturing Director/Plant Manager for the Villalba Campus in Puerto Rico. From 2004 to 2008, held positions at J&J’s Lifescan Products division including Operations & Plant Manager; and Sr Manufacturing Director, providing leadership for the Blood Glucose Strip business to include responsibility for supply chain, distribution, operations, process engineering, quality assurance, finance, and human resources. Started in the medical device industry over 20 years ago at Stryker holding roles of increasing responsibility to include Quality Engineer, Production Supervisor, and Human Resource Representative before ultimately serving as the Director of Quality Assurance and Regulatory Affairs for Stryker Medical and then as the Vice President, Plant Manager for the Endoscopy Division.
In addition to his broad business perspective, Wilf brings the experience of being responsible for division-wide quality assurance systems, regulatory compliance programs and other compliance practices while demonstrating exceptional leadership skills facilitating business turn-around and compliance improvements while establishing a sustainable customer focused culture.
Graduated from Cornell University with a BS in Engineering earning a dual major in Electrical and Material Science Engineering. Graduated with distinction from the Thunderbird School of Global Management, earning a Global Master in Business Administration. Prior to entering the medical device industry, served in the United States Navy from 1986 to 1992 as a Lieutenant in Submarine Warfare.
Resides in Mansfield, MA with his wife, Velma Ayala-Zayas. Family includes two sons, Guillermo Ruiz, and Diego Ruiz who reside in Puerto Rico; and two step-daughters, Jennifer and Stephanie Matos-Ayala.
Angie began her career working for a small laboratory and pathologists and began her career in quality there. As a phlebotomist, she was responsible for daily quality checks of reagents and some clinical testing such as CBCs, chemistry profiles, PTs, PTTs, and many more.
Later, a career move to a major electronics company gave her global experience in quality and regulatory. There she worked internally and externally conducting audits and managing teams for supplier excellence.
This led to her career at BSI where she has been for over 20 years. Here, she has been a full-time auditor, an Area Manager and now Project manager for two medical device schemes at BSI, the “Canadian Medical Devices Conformity Assessment System” or CMDCAS, and “Medical Devices Single Audit Program” or MDSAP.
Mary is VP of Regulatory Affairs/Quality Systems and a Senior Principal Advisor at RCRI. She has worked for over 30 years in medical device and biotechnology industries. She brings experience in strategic regulatory, quality, R&D, and business development roles to her project work. As a Senior Principal Advisor for RCRI, Mary has worked with clients to develop domestic and international regulatory strategies, draft submissions, and negotiate their approval by FDA and/or other regulatory agencies. Leveraging her years of R&D and product development experience, Mary often works with product development teams or early-stage companies during initial phases of product design to provide regulatory support and guidance. Her chemistry and biotechnology expertise help to efficiently support project involving combination products or medical devices incorporating biological materials.
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 the Drug Enforcement Administration. 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 has been identified in Chambers USA: America’s Leading Lawyers in Life Sciences: Regulatory/Compliance and the International Who’s Who of Life Sciences Lawyers. He serves on the Board of GaBio, the PDMA Alliance (as the General Counsel), and the Atlanta Jewish Academy. He also sits on a number of editorial boards for life science journals. 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.
Dr. Mullis is the Director of the UGA BioPharma Regulatory Affairs Graduate Education Programs within the College of Pharmacy at the University of Georgia. He also holds the rank of Associate Professor in the College of Pharmacy, Department of Pharmaceutical and Biomedical Sciences. Dr. Mullis serves as 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. Dr. Mullis has over 40 years of successful senior management experience working in the FDA regulated health care industry including 17 years as a consultant with companies. He has extensive experience filing IDEs, INDs, 510(k)s, PMAs, and other marketing applications with FDA and international regulatory agencies. He has assisted clients with resolving submission problems, cGMP, GCP and other regulatory compliance issues. Dr. Mullis holds a BS degree from Appalachian State University, a Master of Science from The University of Tennessee, and a Ph.D. from The University of Tennessee. He is a Fellow in the Regulatory Affairs Professional Society that recognizes senior regulatory affairs professionals for their continued significant contributions and leadership in the advancement of the profession and is a member of the AGRE Board of Directors.
Melissa Gaynor O’Connor
Melissa Gaynor O’Connor, M.S., RAC has 17 years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization. She currently holds the position of Vice President of Quality Assurance and Regulatory Affairs for StimLabs, LLC, a regenerative medicine company specializing in the processing of human tissue. Melissa is also a consultant for REGSolutions, LLC., a boutique consulting firm providing regulatory solutions and quality systems for the medical device industry.
Melissa has over 6 years of experience in Quality System design, implementation, maintenance, and compliance. Prior to joining StimLabs, Melissa held Quality leadership positions serving as the Management Representative, Head of Quality, and Official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc., a global manufacturer of adhesive based Class II medical devices for wound closure. Melissa began her career at Kimberly-Clark Health Care, where she held positions in Regulatory Affairs, Product Development, and Process Engineering over her 11 year tenure. Her work in medical device product development for Kimberly-Clark resulted in the issuance of 4 US patents and the commercialization of several new surgical and infection control products. In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development including pre-market approval requirements for the U.S and E.U.
Melissa is a member of the Regulatory Affairs Professional Society (RAPS) and holds an active RAC certification. She is an active Chapter Leader for the RAPS Atlanta Chapter and participates in planning for local events. Melissa holds a BS degree in Biological Sciences from the University of Georgia and a MS Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs. Outside of work, Melissa is a competitive horseback rider and recently achieved a personal milestone by earning her Bronze Medal Rider Award from the United States Dressage Federation.
Russ is Quality Systems Integration Leader on the Global Quality Systems team at Halyard Health headquarters in Alpharetta, GA. His 24 years in Quality Assurance include 17 years of medical device and pharmaceutical experience. Russ has experience as plant Quality Manager at several Kimberly-Clark manufacturing facilities and with Halyard Health on the Global Quality Systems team. Russ led the quality systems work stream when Halyard Health was created as a spinoff from Kimberly-Clark in 2014. His current focus is on quality systems integration of acquisitions, global quality systems improvement and implementation of ISO 13485:2016.
Anne Reid is the Deputy Program Director in the Office of Medical Device and Radiological Health Operations. She is a career FDA federal service veteran. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a Master’s degree in Food Science and segued into FDA’s laboratory science regulatory operations. Here she gathered twenty years of hands on involvement with practical applications, method development, and sophisticated progressive technology and instrumentation. In addition to her strong technical and scientific background, Anne progressed in supervisory, managerial, and executive responsibilities within ORA. Since 2000 Anne has held supervisory and branch director positions. In 2010 she became the Deputy Director of ORA’s Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. Anne has been a valued member of the ORA Senior Leadership Team for the past five years. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment until permanent leadership was established.
Ibim B. Tariah, Ph.D.
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).
David Van Houten is an FDA Compliance Officer for the Medical Device and Radiological Health program area stationed in FDA’s Nashville Office. He’s been working for the FDA for the past 27 years; for the first 19 as an Investigator in the New York and New England areas, followed by six years as a Supervisor in Phoenix, AZ and Nashville, TN, and for the past two years as a Compliance Officer in Nashville, TN. He’s completed all of FDA’s Medical Device training courses, has conducted hundreds of domestic and foreign medical device inspections as an Investigator, and has reviewed numerous medical device inspection reports as a Supervisor. He also achieved Level II Medical Device Certification in 2007, while he was an Investigator.