Ninth Annual Medical Device Quality Congress Managing the “Big Five” Quality Concerns

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Devicemakers face hundreds of millions of dollars in settlements and penalties — and jail time, too — as the reborn FDA gets tough.

What if you could slash your exposure to FDA sanctions? Even get the number down to zero?

Register now

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

At another devicemaker, the ex-president and two other former executives went to jail.

The FDA is cracking down on devicemakers as never before. You may know that. But did you realize that fully 93% of device warning letters fall into just five categories?

Suppose you could fix those five areas. Why, then, you might actually cut your FDA sanctions exposure all the way down to zero.

You might. You could. You can. And now ... you will.

Mark your calendar for Wednesday-Friday, May 16-18, 2012. It’s the event that a prior attendee called “the best conference for medical device manufacturers” — the Ninth Annual Medical Device Quality Congress, sponsored by FDAnews.

Come to Washington this spring for this once-a-year opportunity to:

  • Hear FDA officials lay out agency plans and objectives
  • Learn from private-sector experts, consultants and lawyers, folks who’ve paved proven paths to excellence
  • Listen to every word as fellow devicemakers recount “war stories” — case studies of compliance missteps ... how they spotted the problems ... what they did to fix them ... what you can do to avoid them.

May is glorious in the Nation’s Capital, but you may get little chance to smell the flowers. You’ll be busy learning about the Big Five Fix™ that could cut exposure to near zero in the five areas where the FDA targets 93% of its enforcement. Here’s just a smattering of what you’ll discover:

  • Avoiding common supplier issues in medical device inspections
  • 3 steps to assuring the effectiveness of recalls
  • How centralized quality management can lead to compliance violations
  • How to review the CAPA file prior to closing (important, because the next time you open it probably will be in front of an FDA investigator!)
  • Structuring supplier quality contracts to assure the materials you receive are within specifications
  • Best practices for identifying and addressing product failures
  • What to do if a product failure triggers product liability litigation threats
  • How shady suppliers pass off defective products to unsuspecting devicemakers
  • Improving product application quality and cutting regulatory review times via
    better-written compliance documents
  • Getting senior management buy-in for improved quality results
  • How eMDR will change quality management and reporting responsibilities
  • And much more!

We’ve invited four present and former FDA officials as speakers, including:

  • Steven Silverman, Director, Office of Compliance, CDRH
  • Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH
  • Thomas Gross, Acting Director, Office of Surveillance and Biometrics, CDRH
  • Joni Joy, Deputy Director, Office of Device Evaluation, CDRH, FDA

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 whose names you may recognize, including:

  • Dr. Vinny Sastri, President, Winovia LLC
  • “This event is the best conference for medical device manufacturers. Always state-of-the-art topics and insightful talks from FDA officials. Relevant and comprehensive every year.”
    — Paul A. Arrendell, VP-Global Quality, Kinetic Copncepts Inc.

  • Salena Zellers Schmidtke, BioInjury LLC
  • Manuel Urena, Regulatory Affairs Manager, ResMed Ltd
  • Michael Crader, VP-Global Regulatory Affairs/QA, Teleflex
  • David Orton, Senior Director, Corporate Compliance, Covidien
  • Elizabeth Blackwood, Vice President, Supply Chain Quality Strategy, Johnson & Johnson
  • Patricia Shrader, VP-Corporate RA, Medtronic

“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 C. (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



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

May 16-18, 2012
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003
Tel: +1 (301) 822-9200
Room rate: $199 single or double (plus 13% tax)
Hotel reservation cutoff date: April 24, 2012


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Complete Congress
(Includes: Conference and Pre-Conference Workshop)


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Pre-conference Workshop Only


Livestreaming Full Conference
(including 24/7 access to the content for six months after the event)


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3-4 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
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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.