|By PR Newswire||
|February 21, 2014 10:14 AM EST||
FALLS CHURCH, Va., Feb. 21, 2014 /PRNewswire-iReach/ -- Device Supplier Controls
Does the FDA's Next 483 Have Your Name on It?
**FDAnews Virtual Conference**
Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST
Dr. Tejero de Rio, Lead Consumer Safety Officer, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA is presenting the opening Keynote at FDAnews' Device Supplier Controls Virtual Conference on Feb. 26.
Opening Keynote: Supplier Controls — FDA Medical Device Requirements
The FDA has been actively focusing on the protection and integrity of contract manufacturers and suppliers for medical devices. Understanding the FDA's approach is essential to ensuring compliance and avoiding problems. This session will take attendees through the latest FDA policies and processes.
Attendees will learn:
- Common contract manufacturer and supplier issues the FDA uncovers in medical device inspections and how firms can avoid them
- How suppliers, contractors and consultants should meet the requirements established by the finished device manufacturer
- After the initial assessment or evaluation, tips for determining the combination of assessment methods, and how to include third-party or product certification
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 a company has, the more opportunities they give the FDA to find fault with their operations.
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 is designed especially to take the headaches out of working with an ever increasing number of suppliers. Sign up to attend and take home practical tools and invaluable tips that will help devicemakers be more confident that their outsourced work will not result in a Form 483 or warning letter.
There's simply so much that can go wrong when outsourcing. On Wednesday, Feb. 26, a panel of experts will spend the day, 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 a supplier control approach that will work for large or small companies
- Managing supplier controls over the long haul to create good business relationships and assure FDA compliance
- What motivates a supplier to do business
- How to test SOPs against the most commonly cited sections of 21 CFR 820.50
- Verifying that 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 to have at the ready to print out and produce the moment the FDA inspector demands them
Device Supplier Controls is a must-attend event for colleagues from the manufacturing floor to materials management, and the legal counsel's office to the executive suite.
- Quality assurance/quality control
- Materials management
- Packaging and labeling
- Plant engineering
- In-bound testing and certification
- Regulatory affairs
- Legal counsel
Maria Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, 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.
Meet the Faculty
John Avellanet, Principal Consultant, Cerulean Associates
David Parkin, Supplier Development Manager, Boston Scientific
Jackie Torfin, Vice President of Quality, Heraeus Medical Components
Mike Heyl, Partner, Hogan Lovell (invited)
Device Supplier Controls
Does the FDA's Next 483 Have Your Name on It?
**FDAnews Virtual Conference**
Feb. 26, 2014 — 10:00 a.m. – 4:00 p.m. EST
$1,297 per site -- includes virtual conference registration and audio cds and transcripts
Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Media Contact: Michelle Butler, FDAnews, 703-538-7665, [email protected]
News distributed by PR Newswire iReach: https://ireach.prnewswire.com
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