Device Supplier Controls

Virtual Conference

Device Supplier Controls:
Does the FDA’s Next 483
Have Your Name on It?

Your office, Feb. 26, 2014

Your Instructors

M. Isabel Tejero, MD PhD, Acting Lead, Quality Systems Working Group, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA
Dr. Tejero was born in Spain where she trained as a physician. After practicing as a family physician in her home country, she moved to the United States and earned a PhD in Integrative Physiology. Conducting cardiovascular research in the US, she reached the position of Research Assistant Professor at George Washington University. In 2009, she joined the Office of Compliance at CDRH, where she works as a Consumer Safety Officer enforcing medical device regulations. For the past two years, she has specialized in the evaluation of premarket drug applications classified as combination products with a device constituent.

John Avellanet, Principal Consultant, Cerulean Associates
John Avellanet is a former medical device and biopharma executive who created, developed and ran a Fortune 50 subsidiary's records management and information technology departments. He co-founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on cost-effective FDA compliance. He was the lead author for the US RAPS supplier management certification courses, and is  is a regular columnist for the quarterly Journal of Commercial Biotechnology where he writes on the practical aspects of FDA compliance and quality systems, and the magazine Pharmaceutical Processing where he writes about IT compliance issues such as Part 11 and Annex 11. In 2011, Mr. Avellanet was selected by the US Department of Justice to oversee a multi-million dollar medical device consent decree.

Jackie Torfin, Vice President of Quality, Heraeus Medical Components
She began her almost 20 year career in in-vitro diagnostics/medical devices and worked in quality control, quality assurance and project management for Beckman Coulter for more than nine years.  She is certified as a notified body auditor for both Europe and Canada.  Prior to joining Arizant, Ms. Torfin was the Director of Quality Assurance/Quality Systems for CIMA Labs Inc., a contract development and manufacturing organization, where she managed more than 15 pharmaceutical partnerships.  Her move to PDL BioPharma/Genmab as Director of Quality brought with it a change in focus to managing CMO manufacturing organizations from the sponsor’s perspective.  She was responsible for the management of more than 20 different CMOs.

David Parkin, Supplier Development Manager, Boston Scientific
He currently oversees the San Clemente, CA supplier development activities. Prior to this position he was the principal supplier development engineer at Cameron Health, a start-up device company where he worked directly with suppliers to improve capability and stability during a time of volume ramp-up. Mr. Parkin also served as principal sourcing continuity engineer at Medtronic. There he maintained a reliable material supply to the company. Develop new and replacement components. He drove quality and improvement projects with suppliers and performed supplier audits to ISO 13485 standards. Manage and mentor new engineers, technicians, and interns. Mr. Parkin received a BS in Industrial Technology – Product Development from The University of Wisconsin – Stout.

Alan G. Minsk, Partner, Food and Drug and Government and Regulatory Practices
Mr. Minsk was recently recognized by Chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013. Mr. Minsk also serves as practice leader of the Food and Drug Practice, which is recognized in U.S. News Media Group and Best Lawyers 2011–12 "Best Law Firms" rankings as one of the top food and drug practices in the nation. He serves as general counsel of PDMA Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. He focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic and food companies, on all legal and regulatory matters relating to the FDA and the DEA.