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:

Confirmed FDA Speakers

  • Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA
  • Ronny Brown, Chief, Recall Branch, Division of Risk Management Operations, OC, CDRH, FDA
  • William MacFarland, Director, Division of Manufacturing and Quality, OC, CDRH, FDA
  • Erin Keith, Director, Division of Anesthesiology, General Hospital, Respiratory,  Infection Control and Dental Devices, CDRH, FDA
  • Dr. Suzanne Schwartz, Director, Emergency Preparedness/Operations and Medical Countermeasures, OCD, CDRH, FDA
  • Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA, Columbus, OH (invited)

Experts from Industry

  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding; former FDA Deputy Associate Commissioner for Regulatory Operations (MDQC Co-chair)
  • Elaine Messa, President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA (MDQC Co-chair)
  • Karl Vahey, Director of Compliance, International RA/QA, Covidien
  • Larry Kopyta, Vice President, Quality Assurance & Regulatory Affairs, Omnyx
  • Bob Marshal, Director of Business Development, Regulatory & Quality Solutions, LLC
  • Patrick Caines, Director, Product Surveillance, GE Healthcare
  • Paul Brooks, Vice President and Country Manager, BSI Americas
  • Vinny Sastri, President, WINOVIA
  • Steven Walfish, President, Statistical Outsourcing Service
  • John Avellanet, Managing Director & Principal, Cerulean Associates
  • Dan O’Leary, President, Ombu Enterprises
  • Deb Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions
  • Julie Larsen, Principal, Director Inspection Readiness Services, BioTeknica

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:

  • Understanding how to review complaints and CAPAs with a risk management mindset to prioritize valuable time and resources
  • What do regulators want to see when they examine risk management files? Is there a sweet spot between too little information and too much?
  • Handling data requests, particularly for electronic records — best practices from inspectional veterans
  • What's the latest on the specialization and training that FDA investigators are receiving?
  • Understanding how manufacturing processes could render previously believed safe materials unsafe
  • How to properly review Directive 93/42/EEC and assure you're classifying your device correctly — failure to do so causes nothing but waster time and money
  • How to examine the discrete or continuous statistical data you collect. With testing involving discrete data, you'll be doing simple pass/fail tests. With continuous data, you'll measure the output of a device, such as cycle times, voltages or pressures
  • How to address FDA inspector's questions during on-site visits when asked about what constitutes a reportable event and what does not
  • Requirements for MDRs on events occurring outside the US
  • How to conduct an on-site supplier audit applying risk management
  • And much, much more

Review the entire Congress 2015 agenda.

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.