Medical Device Quality Congress
Managing the “Big Five” Quality Concerns
More than 90% of FDA device warning letters fall into 5 categories:
At FDAnews, we call them the “Big Five.”
If you’re concerned about quality issues — and who isn't? — you very likely need our Big Five FixTM.
Where do you get it? Sign up TODAY for the best-attended annual conference for devicemakers, now in its 11th year.
The "can't-miss" annual conference
Over the past 10 years, thousands of device professionals have attended Medical Device Quality Congress (MDQC) and benefited from the unmatched educational sessions presented by industry experts and FDA officials.
For 2014, FDAnews has crafted a groundbreaking three-day agenda that will provide you with a thorough overview of all the key issues confronting devicemakers, with actionable information and insights that you can take back and apply immediately.
Register now with the confidence that you'll learn how to improve your quality systems, relying on our tightly focused sessions led by industry experts and FDA officials. These presentations will feature detailed case studies and interactive panels; you're sure to gain fresh ideas and tips that you'll be able to take back to your company.
And one thing's for sure: you'll leave the Congress with a Big Five FixTM, the
knowledge and the actionable items you need to address any of your Big Five
quality concerns and improve your quality systems.
If you can only attend one conference in 2014, this is the one for you.
Just read the words of past attendee Paul Arrendell, Vice President of Global Quality at Kinetic Concepts, Inc.:
“The annual Medical Device Quality Congress is the best conference for medical
"Always state-of-the-art topics and insightful talks from FDA officials.”
Here's just a sample of specific issues that you'll hear about when you attend MDQC 2014:
- Best practices for identifying and addressing product failures, including how to preemptively position your 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. (This is important since the next time you open that CAPA will probably be in front of an FDA investigator.)
- 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 your 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 your compliance with the FDA’s Aug. 2015 deadline.
And much, much more.
But that's just the beginning. This year you can increase your personal knowledge (and the value of your trip to the Congress) by attending two invaluable total-immersion workshops.
Start out on Tuesday morning, June 24, in the pre-conference workshop Harness the Power of Text Mining — Using the FDA’s Recall Data to Identify and Isolate Root Causes of Device Nonconformances. Nonconformance reports are written by different people in different areas of your business. That's why they often use different words or ideas to report the same problem. During this workshop, the instructor will teach devicemakers, using live FDA data, how text mining can help them analyze FDA data and determine how their devices and other products in their class are being reported and if there are trends that show potential problems they may not anticipate.
And, wrap up your three days on Thursday, June 26, with the full-day session, Medical Device Supplier Qualification and Management: Practical Approaches to Cost-Effective Implementation.The average drug or device maker has more than 600 product suppliers, and each should be categorized by risk. Many devicemakers — small and large — are having trouble with these assessments. Compounding the challenges is the need to actually go out and audit your most important suppliers without blowing your budget. This presentation takes the latest guidance and regulation and shows you cost-effective, practical tools and methods to maintain a complaint supplier management program.
With so much you need to stay current on, it's a real challenge to be a device or diagnostics professional today. That's why attending the 2014 edition of MDQC is an absolute must. Just look at how attendees have raved about the Congress in previous years:
“I liked the breadth of subjects and the freshness of the information delivered, much of which can be applied as a gap analysis or bench mark against my company’s practices. I’ve been to this conference before and look forward to it each year.”
“Topics were current and well presented.”
Scott Tabb, Supplier Quality Manager
Medtronic, Surgical Technologies
“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
“Very thorough presentations by excellent presenters.”
Craig Henderson, Quality and Regulation Manager
Pathfinder Therapeutics Inc.
One final note on the benefits of attending MDQC: When you're in Bethesda, you're in the FDA's backyard. This is a rare chance to interact for three days with multiple FDA officials.
When you consider you'll also meet top device professionals from around the country, it's easy to see why the 11th Annual Medical Device Quality Congress is unequalled by any other annual event – and a must-attend for you.
Please take advantage of this unique opportunity. Register TODAY.