Device Supplier Controls

Device Supplier Controls - Webinar CD/Transcript

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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:

  • In a rare use of its powers, the FDA is requiring California devicemaker Medical Device Resource to get a third-party audit of corrections relating to a slew of serious manufacturing and quality assurance deficiencies, and to verify the audit to the agency by March 1, 2014.  The FDA found that the devicemaker had not evaluated its sterilization contractor. “Your firm identified the contractor as a critical supplier but failed to provide a vendor questionnaire or vendor survey as required by your firm’s vendor approval procedure."  The company’s vendor approval procedure also fails to clearly define the criteria for approval or the quality data to review when reevaluating a vendor.
  • According to a recent Form 483, Estill Medical Technologies in Dallas, TX, is not adequately monitoring its contract manufacturer to ensure product control after rework to correct nonconformances. A June 25 to July 3, 2013 inspection found the company did not evaluate its contract manufacturers’ ability to meet its quality requirements and had not established a supplier quality document for several major component suppliers for contract manufacturers of its blood and IV fluid infusion warmers.
  • The FDA is also maintaining pressure on Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants.  In a 483, the agency found that an out-of-specification result was not thoroughly conducted to detect root cause. The company linked the cause to raw materials, but had not previously audited the supplier.
  • R82, a Gedved, Denmark, wheelchair manufacturer, has received an FDA warning letter for quality violations, including evaluating suppliers by the wrong standards. The company’s quality procedure shows that it evaluates suppliers based on purchase volume and the possibility of supplier replacement. However, R82 does not evaluate suppliers based on their ability to meet quality metrics and other requirements.

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:

  • What non-compliance issues most frequently trigger an audit
  • Understanding global supplier monitoring requirements: Can an FDA-centric program fulfill international requirements?
  • Best practices for prioritizing your supplier control approach that will work if your company is large or small
  • Managing your supplier controls over the long haul to create good business relationships and assure FDA compliance
  • What motivates a supplier to do business with you
  • How to test your SOPs against the most commonly cited sections of 21 CFR 820.50
  • Verifying that your supplier dossiers contain the records FDA inspectors want to see
  • How to identify the warning letters that include hidden FDA requirements that tripped other companies up
  • Critical documents you need to have at the ready to print out and produce the moment the FDA inspector demands them

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:

  • Quality assurance/quality control
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • In-bound testing and certification
  • Regulatory affairs
  • Legal counsel

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.

  • Manufacturing
  • QA/QC staff
  • Legal and regulatory affairs
  • Risk management and design operations
  • Compliance officers
  • Executive management
  • In-house counsel
  • Outside counsel

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.