Tenth Annual Medical Device Quality Congress From Risk Management to Postmarket Surveillance

Quantity Discounts
1 - 9999
1 - 9999
1 - 9999
1 - 9999
1 - 9999
1 - 9999

Exclusive Interview with Jay Crowley
Senior Advisor for Patient Safety, CDRH, FDA

Exclusive Interview with Jack Garvey
Compliance Architects®

Exclusive Interview with Steve Niedelman
King & Spalding, 2013 MDQC Co-chair

Exclusive Interview with Heather Rosecrans
Greenleaf Health

Exclusive Interview with Rosalind Parkinson
Ohio State University Wexner Medical Center

We're not here to scare you. We're just reporting some facts...

The number of medical device product recalls is soaring.

In 2007, 1,279 medical device products were recalled – that number skyrocketed to 3,211 in 2011, according to data collected by a recent report overseen by a former FDA commissioner of regulatory affairs.

Here are some more facts:

Recently, a large device manufacturer got hit for $286 million in FDA settlements and penalties.

It was worse for another devicemaker...the ex-president and two other former executives went to jail.

Medical device quality is no longer an option. Get it right, or get hit hard.

We've put together a world-class group of experts who will educate you and provide you with the tools and strategies you need to go back to your shop and make certain your quality program is ready for the FDA.

Register now

Come for this valuable opportunity to:

  • Hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered
  • Learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office
  • Network with other professionals who understand your challenges; share war stories and insights over a drink.

We've worked with experts versed in all aspects of medical device quality to bring you the best in the business. You've told us the most important challenges you face. And we've put together a conference program designed to answer your tough questions. Here's a look at some of the topics:

  • Why the time is now 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!

New for 2013!
FDA Expectations for Managing and
Auditing Supplier Quality
Full-Day Training Session — Thursday, June 6, 2013

In December 2012, the FDA proposed the creation of a new Division of International Compliance Operations within CDRH's Office of Compliance as part of the center’s increased international supply chain focus.  Domestic — and overseas — inspections are also ramping up amid mushrooming international component sourcing and overseas contract manufacturing.

In light of these new changes, FDAnews and EduQuest have joined forces to present, FDA Expectations for Managing and Auditing Supplier Quality.  This full-day, in-depth training session will significantly improve your supplier management program and avoid 483s, warning letters and potential patient injuries.

Expert Instructors:
Martin Browning, President and Co-Founder, EduQuest
Janis Olson, Vice President of Quality and Regulatory Services, EduQuest

You'll hear the latest thinking from key FDA officials, including:

  • 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
  • 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
  • Jay Crowley, Senior Advisor for Patient Safety, CDRH

Register now

Our co-chairs, Steven Niedelman and Elaine Messa, are former top FDA officials as well. 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.

This all-star cast is joined by 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

“Very thorough presentations by excellent presenters.”
— Craig Henderson, Quality and Regulation Manager, Pathfinder Therapeutics Inc.

Bonus Pre-Conference Morning Workshop

Arrive early and attend the special Pre-Conference Workshop, Writing for Compliance: Approaches and Methods for Writing High-Impact, Persuasive Compliance-Related Documentation within FDA-Regulated Companies. Learn the principles and acquire the tools you need to practice this essential specialty. Mr. Garvey shares the fruits of more than 25 years of experience in the area.

Presenter: John (Jack) Garvey, Esq., Principal, Compliance Architects®

  • Executive management
  • Regulatory affairs
  • Quality assurance/quality control
  • Research and development
  • Training directors
  • Compliance officers
  • Manufacturing and contracting
  • Release management
  • Consultants/service providers

Register now


Gold Sponsors

For exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or cmcmullen@fdanews.com

June 4–6, 2013
Doubletree Bethesda Hotel
8120 Wisconsin Avenue
Bethesda, MD 20814
Toll free: (800) 560-7753
Tel: +1 (301) 652-2000
Room rate: $199 plus 13% tax
Reservation cut-off: May 14, 2013

Regular Rate
Preconference Workshop Only — June 4
New for 2013! FDA Expectations for Managing and Auditing Supplier Quality - Full Day Training Session Only — June 6
Medical Device Quality Congress (MDQC) Only — June 4–5
Preconference Workshop + MDQC — June 4–5
MDQC + FDA Expectations for Managing and Auditing Supplier Quality - Full Day Training Session — June 4–6
Preconference Workshop + MDQC + FDA Expectations for Managing and Auditing Supplier Quality - Full Day Training Session — June 4–6

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of two or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund or credit — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.