FDAnews Announces: 13th Annual Medical Device Quality Congress: Building a Culture to Succeed, March 15-17, 2016, Rockville, MD

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Now in its 13th year, FDAnews' Medical Device Quality Congress (MDQC) has become the indisputable must-attend annual event for medical device and diagnostics professionals. Once again for 2016, the co-chairpersons — Steven Niedelmen, and Elaine Messa — have crafted a groundbreaking three-day agenda that will provide attendees with a thorough overview of the key issues confronting devicemakers today.

13th Annual MDQC

13th Annual MDQC

Add a quotable“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.

13th Annual Medical Device Quality Congress:
Building a Culture to Succeed
**Presented by FDAnews**
March 15-17, 2016 – Rockville, MD
http://www.fdanews.com/mdqc

Now in its 13th 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.

Once again for 2016, 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 attendees with a thorough overview of the key issues confronting devicemakers today.

Where other conferences give attendees the 30,000-foot view, the 13th Annual Medical Device Quality Congress puts manufacturers on the runway, in the control tower and at the controls to understand the nuts and bolts of FDA quality expectations for medical devices.

With the 13th 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:

FDA Speakers

  • William MacFarland, Director, Division of Manufacturing and Quality, OC, CDRH, FDA (invited)
  • Jan Welch, Medical Products Program Director, ORA, FDA (invited)
  • Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA (invited)
  • CPT Sean Boyd, Acting Director, Office of Compliance, CDRH, FDA (invited)
  • Dr. Seth Carmody, Staff Fellow, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA (invited)

Speakers from the Industry

  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding; former FDA Deputy Associate Commissioner for Regulatory Operations (Co-chair)
  • Elaine Messa is President of the Medical Device Consulting at NSF Health Sciences former Director of the Los Angeles District, FDA (Co-chair)
  • Karl Vahey, Senior Director Manufacturing Quality, Europe and Asia, Medtronic
  • John Avellanet, Managing Director & Principal, Cerulean Associates LLC
  • Dan O’Leary, President, Ombu Enterprises
  • Joe Pinto, Executive Vice President & Chief Operating Officer, Performance Review Institute

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 devicemakers improve their quality systems — and more.

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 U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting.

Elaine Messa is president of the Medical Device Practice at NSF Health Sciences. She has over 30 years of experience in FDA regulation of medical devices, and has focused on developing and implementing compliant quality systems for medical devices in the U.S. Elaine brings in-depth and broad knowledge of the compliance and regulatory environment, including quality systems, corrective action plans, and managing Form 483 and warning letter responses.

Conference Details:
13th Annual Medical Device Quality Congress:
Building a Culture to Succeed
**Presented by FDAnews**
March 15-17, 2016 – Rockville, MD
http://www.fdanews.com/mdqc

Tuition:
Early Bird Registration (until Feb. 5, 2016):

  • Congress Only $1,447
  • Enhanced Congress $1,697 – includes pre-conference workshop
  • Complete Congress $2,547 – includes pre-conference workshop and post-conference supplier controls and management training session

Additional pricing options are available online.

Easy Ways to Register:
Online: http://www.fdanews.com/mdqc
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
+1 (703) 538-7665
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