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Device Supplier Controls: Does the FDA’s Next 483 Have Your Name on It?
The medical device industry is struggling, with a forecast of single-digit overall growth for 2014.
To cope with that, devicemakers are outsourcing more and more of their critical operations and materials, trying to wring out costs and improve their profitability.
The unintended consequence?
A much, much greater risk of supplier control violations. After all, the more suppliers you have, the more opportunities you give the FDA to find fault with your operations.
But there are ways to significantly lower your risk.
Some devicemakers say they have as many as 400 outsourced contract manufacturers and suppliers.
It's no surprise, then, that it has become increasingly difficult to manage them and be sure that all raw materials, finished products and services meet the devicemaker’s required specifications as well as comply with FDA regulations.
This FDAnews virtual conference cd and transcript set is designed especially to take the headaches out of working with an ever increasing number of suppliers. Order today and you will take home practical tools and invaluable tips that will help you be more confident that your outsourced work will not result in a Form 483 or warning letter.
Now, in case you're not particularly worried, you should be. Every day brings new examples of device supplier control related problems:
There's simply so much that can go wrong when you're outsourcing. A panel of experts spends the day with you, identifying and discussing such key problem areas as:
The Device Supplier Controls virtual conference CD and transcript is a must for colleagues from the manufacturing floor to materials management, and the legal counsel’s office to the executive suite. Make sure to order if you work in:
Whether you're a device manufacturer, diagnostics manufacturer, contract manufacturing organization, or a raw materials and sub-assembly manufacturer, this is a godsend. You don't have to face the difficulties with outsourcing alone.
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.
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