FDAnews Announces: Save The Date for 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/MDQCSaveTheDate

More than 90% of FDA device warning letters fall into 5 categories: 1. Risk management, 2. Design control, 3. Supplier quality, 4. QSR compliance and 5. Postmarket surveillance. FDAnews calls them the “Big Five.”

If devicemakers are concerned about quality issues then they very likely need the Big Five FixTM.

Over the past 11 years, thousands of device, diagnostic, LDT and combination product professionals have attended Medical Device Quality Congress (MDQC) and benefited from the unmatched educational sessions presented by industry experts and FDA officials.

For 2015, FDAnews has crafted a groundbreaking three-day agenda that will provide a thorough overview of all the key issues confronting the industry, with actionable information and insights that can be taken back and applied immediately.

Attendees should save the date — or lock in a discounted registration now — to learn how to improve their quality systems, relying on tightly focused sessions led by FDA officials and industry experts. These presentations will feature detailed case studies and interactive panels.

And one thing's for sure: attendess will leave the Congress with a Big Five FixTM, the knowledge and the actionable items needed to address any Big Five quality concerns and improve quality systems.

Here's just a sample of specific issues that attendees heard about while attending last year’s Congress:

  • Best practices for identifying and addressing product failures, including how to preemptively position a company as transparent and compassionate while minimizing the appearance of negligence in the face of product liability litigation.
  • How pushing quality management down to the plant and site level — vs. centralized quality management — lends itself to greater compliance improvements.
  • How to review the implementation, effectiveness and completion of the CAPA file prior to closing.
  • How the 5 top concerns of supplier risk management (product risk, business risk, recalls risk and liability risk) are linked and how to assure that internal SOPs and process cover them all.
  • How to choose whether to use the FDA’s eSubmitter system or HL7 solutions for eMDR — each come with pros and cons and could impact compliance with the FDA’s Aug. 2015 deadline.
  • And much, much more.

With so much to stay current on, it's a real challenge to be a device, diagnostic, LDT or combination product professional today.

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/MDQCSaveTheDate

Tuition:
Early Bird Registration (until February 6, 2015):

  • 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/MDQCSaveTheDate
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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