FALLS CHURCH, Va., April 19, 2013 /PRNewswire-iReach/ -- Tenth Annual Medical Device Quality Congress
From Risk Management to Postmarket Surveillance
**Presented by FDAnews**
June 4-6, 2013 — Bethesda, MD
FDAnews has put together a world-class group of experts who will educate attendees of the 10th Annual Medical Device Quality Congress and provide them with the tools and strategies they need to go back to their companies and make certain their quality program is ready for the FDA.
Top FDA officials will be on hand to provide full presentations — including Q&A sessions — and participate in panel discussions. Confirmed speakers include:
- Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA
- Ron Brown, Chief, Recall Branch, Division of Risk Management Operations, Office of Compliance, CDRH
- Jay Crowley, Senior Advisor for Patient Safety, CDRH
- Victoria Schmid, Consumer Safety Officer, MDR Policy Branch, Office of Surveillance and Biometrics, CDRH
- Sharon Kapsch, Chief, MDR Policy Branch, Office of Surveillance and Biometrics, CDRH, FDA
Medical device quality is no longer an option. Get it right, or suffer the consequences.
Looking for proof?
In 2007, the FDA recalled 1,279 medical device products. In 2011, the FDA recalled 3,211 medical device products. Experts predict that number will keep climbing until industry gets a better handle on device quality.
Need more evidence?
Recently, a large device manufacturer got hit for $286 million in FDA settlements and penalties. The news was worse another devicemaker: the ex-president and two other former executives went to jail.
Mark your calendar for June 4-6, 2013. It's the event that a prior attendee called "the best conference for medical device manufacturers" — the 10th Annual Medical Device Quality Congress, sponsored by FDAnews.
Come to Bethesda this June for this once-a-year opportunity to:
- Hear and question FDA officials as they lay out agency plans and objectives.
- Learn from device industry experts, consultants and other experts; take actionable tips and tactics straight back to your office.
- Network with other medical device professionals who understand your challenges; share war stories and insights over a drink.
Attendees will have plenty of time to learn about meeting the latest challenges in the medical device quality arena, including:
- Why now is the time to weigh in on the FDA's new single-audit program
- How to reduce your risk of receiving a 483
- 8 tips for developing Quality System remediation
- Expert Roundtable: What's new in FDASIA, and what should you be doing now to prepare
- Sleep better at night with proven strategies to avoid product recalls
- Secrets of successful risk management systems
- Take the Industry Challenge: Learn what FDA leaders really think of your Adverse Event Reporting regime
- UDI: An all-star cast discusses agency expectations, deadlines and how to integrate UDI into your existing supply chain operations
- Avoid the serious perils of lax design control
- Get ahead of looming regulations on mobile health apps
- And much more!
Conference co-chairs Steven Niedelman and Elaine Messa were once top FDA officials, too. Mr. Niedelman was Chief Operating Officer, FDA ORA, and Ms. Messa headed the Los Angeles District, responsible for the largest import operations in the U.S. Their depth of FDA experience helps them keep speakers focused on attendee's pressing issues.
Mr. Niedelman and Ms. Messa have helped develop an all-star cast of device industry leaders, many of whom are former FDA senior officials whose names you may recognize, including:
- Vinny Sastri, President, Winovia LLC
- Julie Larsen, Director, Inspection Readiness Services, BioTeknica
- Phil Phillips, Consultant; former Deputy Director, Office of Device Evaluation, CDRH
- Heather Rosencrans, Senior Regulatory Advisor, Greenleaf Health; former Director of the 510(k) Pre-Market Notification Program, CDRH
- Dan O'Leary, President, Ombu Enterprises
- Marian Lee, Partner, King and Spalding
- Michael Crader, President, Matrix Resource Solutions
- John (Jack) Garvey, Esq., Principal, Compliance Architects®
Early Bird Registration Through April 26, 2013: $2,547 per attendee for the complete Congress
Regular Registration After April 26, 2013: $2,997 per attendee for the complete Congress
4 Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600
Mail to: FDAnews
300 N Washington St
Falls Church VA US 22046-3431
Media Contact: Jeff Grizzel FDAnews, 703-538-7668, email@example.com
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