Twelfth Annual Medical Device Quality Congress

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Now in its 12th year, FDAnews' Medical Device Quality Congress (MDQC) has become the indisputable must-attend annual event for medical device and diagnostics professionals.

With over 1,700 attendees since 2004, there's simply no other medical device conference that even comes close.

Need more proof?

Just consider MDQC's co-chairs, with a combined 60 years in the industry … our expert speakers, including current and former FDA officials and recognized industry leaders … our unmatched educational sessions, dynamic interactive panels, incomparable case studies and in-depth workshops … and the ultimate benefit of knowing you'll take home substantive knowledge and actionable insights to apply to your job immediately.

Once again for 2015, our co-chairpersons — Steven Niedelmen, lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding and Elaine Messa, President of the Medical Device Practice, NSF Health Sciences — have crafted a groundbreaking three-day agenda that will provide you with a thorough overview of the key issues confronting devicemakers today.

With the 12th Annual Medical Device Quality Congress practically in the FDA's backyard, you have a rare chance to interact with CDRH officials, past FDA-ers and recognized industry experts, including:

Invited FDA Speakers

  • Kim Trautman
  • Ronny Brown
  • Sharon Kapsch
  • Isaac Chang
  • Bill MacFarland
  • Steve Silverman
  • Tahseen Mirza
  • Alford Taylor Jr.
  • Jonette Foy
  • Kyle Myers

Speakers from the Industry

  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations (Co-chairperson)
  • Elaine Messa, President of the Medical Device Practice, NSF Health Sciences, former Director of the Los Angeles District, FDA (Co-chairperson)
  • Paul Brooks, Vice President and Country Manager, BSI Americas
  • Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group
  • Vinny Sastri, President, WINOVIA® LLC
  • Karl Vahey, Director of Compliance, International RA/QA, Covidien
  • Larry Kopyta, Vice President, Quality Assurance & Regulatory Affairs, Omnyx, LLC
  • Steven Walfish, President, Statistical Outsourcing Services
  • Patrick Caines, Director, Product Surveillance, GE Healthcare

With industry experts and FDA officials like these, you'll confidently attend the Congress, knowing you'll return to your office with reliable, tried-and-tested, in-the-trenches knowledge that'll help your improve your quality systems — and more.

Register Today

Here are just a few of the many specific issues that you'll hear about when you attend the 12th Annual Medical Device Quality Congress:

  • Why centralized quality management lends itself to compliance violations
  • Reviewing the implementation, effectiveness and completion of the CAPA file prior to closing (This is important: the next time you open that CAPA will probably be in front of an FDA investigator)
  • How to structure supplier quality contracts to assure you’re receiving materials that are within specifications
  • Best practices for identifying and addressing product failures and how to preemptively position your company as transparent and compassionate while minimizing the appearance of negligence in the face of product liability litigation
  • Ways in which shady suppliers pass off defective products to unsuspecting device companies
  • The value of transforming competent engineers into competent document authors to improve product application quality and reduce regulatory review times
  • Learn how to involve the critical members of your senior management team to make quality system work at all levels — and how they can also influence your compliance culture and strategies
  • How eMDR will change quality management and reporting responsibilities
  • Common supplier issues the FDA uncovers in device inspections and how firms can avoid them
  • How to assure the effectiveness of recalls — 3 steps to make it happen quickly
  • And much, much more

Review the entire Congress 2015 agenda.

But don't just take our word for how much you can expect from the 12th Annual Medical Device Quality Congress. Here are just a few of the kudos and rave reviews we've received over the last eleven years:

“Very pleased that most speakers were directly from industry, either FDA or corporations. Good to hear directly from the source.”

– Rossellen Miller, Product Development Quality Engineer, Terumo Cardiovascular, Inc.

“Topics were current and well presented.”

– Scott Tabb, Supplier Quality Manager, Medtronic Surgical Technologies

“Excellent sessions overall.”

– Nash DeVita, Regulatory Analyst, Sunquest Information Systems

“I really liked the examples, scenarios and practical examples. The 'real life' examples were a great way to drive home the points and examples.”

– Tanya Taft, Sr. Manager, Post Market Clinical, Fresenius Medical

“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, Vice President Global Quality, Kinetic Concepts, Inc.

“Very thorough presentations by excellent presenters.”

– Craig Henderson, Quality and Regulation Manager, Pathfinder Therapeutics, Inc.

Register now

And there are other ways you'll benefit from attending FDAnews' 12th Annual Medical Device Quality Congress.

Make a commitment to yourself TODAY to increase your personal knowledge (and your value to your company!) in the critically important area of risk management.

Sign up to attend both the half-day pre-conference workshop as well as the "total immersion" full-day closing workshop.

You'll start out on Tuesday morning, March 17, in the invaluable workshop Integrating Risk Management into Complaint Management and CAPA Processes.

In just three hours, you'll learn how important risk management can be to you … how including it in your process will allow you to better prioritize and focus on complaints and on CAPA … allow you to free up more of your time to conduct investigations properly … and help you ensure you’re doing more to protect your patients — and your organization.

Then, wrap up the three day conference on Thursday, March 19, with the full-day session, Medical Device Supplier Qualification and Management: Practical Approaches to Cost Effective Implementation.

Devicemakers continue to recognize risk management's value in satisfying regulatory requirements and protecting against problems like today's extended supply chain. But implementing risk management is far from easy. This workshop will help you better understand GHTF guidance documents as well as teach you methods and give you tools to successfully manage a cost effective implementation. You'll receive valuable documents to take back to the office, including a process map, sample questionnaire, reevaluation form, audit checklist and more.

Review the entire Congress 2015 agenda.

There's no doubt: it's a real challenge to be a device or diagnostics professional today.

That's why attending the 2015 edition of FDAnews' Medical Device Quality Congress is more important than ever before.

Why you can't afford NOT to attend: This is your chance to rub elbows for three days with past and present CDRH officials and top device pros from around the country … to pick their brains … absorb their knowledge … and develop contacts who'll be invaluable to you all through the year.

Please take advantage of this truly unique opportunity. Register TODAY.