Falls Church, VA (PRWEB) April 22, 2014
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 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 a thorough overview of all the key issues confronting devicemakers, with actionable information and insights that can be taken back and applied immediately.
Register now with the confidence that attendees will learn how to improve their quality systems, relying on tightly focused sessions led by industry experts and FDA officials. These presentations will feature detailed case studies and interactive panels; attendees are sure to gain fresh ideas and tips that they'll be able to take back to their company.
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 will hear about while attending MDQC 2014:
- 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.
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 a 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 the most important suppliers without blowing the budget. This presentation takes the latest guidance and regulation and shows 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.
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.
11th Annual Medical Device Quality Congress:
Managing the “Big Five” Quality Concerns
**Presented by FDAnews**
June 24-26, 2014 – Bethesda, MD
Early Bird Registration (until May 23, 2014): Complete Congress $2,547
Regular Registration (May 24, 2014 on): Complete Congress $2,997
Additional pricing options are available online.
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.