FDAnews Announces: 12th Annual Medical Device Quality Congress, March 17-19, 2015

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Over the past 11 years, thousands of device professionals have attended Medical Device Quality Congress (MDQC) and benefited from the unmatched educational sessions presented by FDA officials and industry experts. For 2015, FDAnews has crafted a groundbreaking three-day agenda that will provide a thorough overview of all the key issues confronting device makers, diagnostics makers, LDT developers and combination products makers, with actionable information and insights that can be taken back and applied immediately.

12th Annual Medical Device Quality Congress:
Managing the “Big Five” Quality Concerns
**Presented by FDAnews**
March 17-19, 2015 – Bethesda, MD
http://www.fdanews.com/MDQC2015PR

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 … expert speakers, including current and former FDA officials and recognized industry leaders … unmatched educational sessions, dynamic interactive panels, incomparable case studies and in-depth workshops … and the ultimate benefit of taking home substantive knowledge and actionable insights to apply immediately.

Once again for 2015, the 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 a thorough overview of the key issues confronting devicemakers today.

With the 12th Annual Medical Device Quality Congress practically in the FDA's backyard, attendees 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
  •     Jonette Foy
  •     Suzanne Schwartz
  •     Phil Pontikos

Experts 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)
  •     John Avellanet, Managing Director & Principal, Cerulean Associates
  •     Paul Brooks, Vice President and Country Manager, BSI Americas
  •     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
  •     Dan O’Leary, President, Ombu Enterprises
  •     Deb Kacera, Regulatory and Industry Strategist, Pilgrim Software

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

Here are just a few of the many specific issues that attendees will hear about at 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 devices are classified device correctly — failure to do so causes nothing but waste time and money
  •     How to examine the discrete or continuous statistical data collected. With testing involving discrete data, manufacturers will be doing simple pass/fail tests. With continuous data, they’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

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.

Who Will Benefit:

  •     Quality Assurance/Quality Control
  •     Manufacturing and Contracting
  •     Supply Chain Management
  •     Risk Management and Product Lifecycle Management
  •     Executive Management
  •     Regulatory Affairs
  •     Research and Development
  •     Compliance Officers
  •     Consultants/Service Providers

Meet the Co-Chairpersons:
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA.

Elaine Messa is Executive Vice President at NSF Health Sciences. She has more than 30 years of experience in FDA regulation of medical devices, having focused on the development and implementation of compliant quality systems for medical devices in the United States.

Conference Details:
12th Annual Medical Device Quality Congress:
Managing the “Big Five” Quality Concerns
**Presented by FDAnews**
March 17-19, 2015 – Bethesda, MD
http://www.fdanews.com/MDQC2015PR

Tuition:

  •     Preconference Workshop Only

(March 17, 2015) - $597

  •     Device Supplier Quality Training Session Only (March 19, 2015) - $997
  •     Medical Device Quality Congress (MDQC) Only (March 17-18, 2015) - $1,597
  •     Preconference Workshop + MDQC (March 17-18, 2015) - $1,797
  •     Device Supplier Quality Training Session + MDQC (March 17-19, 2015) - $1,997
  •     Preconference Workshop + MDQC +Device Supplier Training Session

(March 17-19, 2015) - $2,497

Additional pricing options are available online.

Easy Ways to Register:
Online:     http://www.fdanews.com/MDQC2015PR
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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