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FDA Compliance

Event: Eighth Annual Medical Device Quality Congress

June 7–9, 2011, in Bethesda, Maryland

Published: Thursday, May 26, 2011 - 13:22

(FDAnews: Falls Church, VA) -- Register today for the Eighth Annual Medical Device Quality Congress, scheduled for June 8–9, 2011, in Bethesda, Maryland. This year the conference will feature more than 15 in-depth sessions headed up by leading quality experts, including sessions led by 10 officials from the Center for Devices and Radiological Health (CDRH) and five former Food and Drug Administration (FDA) officials. FDAnews has pinpointed the top five most important quality issues—risk management, design control, supplier quality, quality systems regulation (QSR) compliance, and postmarket surveillance—and built this year’s program around them.

Attend and you’ll get answers to your toughest questions, including:

• What can you do to improve quality assurance (QA) and engineering processes and better serve patients?
• What about “sister suppliers” and regulations surrounding supplier management?
• What are CDRH’s expectations for postmarket surveillance and signal detection?
• What new problems are field investigators uncovering?
• What are CDRH’s goals and areas of interest for 2011 and beyond?

During two and one-half days of focused sessions and interactive panels, you’ll hear from many of the industry’s top quality experts from companies such as Heraeus Medical, Camstar Systems, Lipid Science, Roche Diagnostics, and CareFusion. The Eighth Annual Medical Device Quality Congress sessions include:

• FDA Update on Supplier Controls
• Managing Global Risk Management Programs to Assure User Needs are Met
• Utilizing Risk Assessment to Manage Original Equipment Manufacturer (OEM)/Contract Suppliers
• Detecting, Controlling and Preventing Quality Problems
• How Electronic Medical Device Reporting (eMDR) Will Change Quality Management and Reporting Responsibilities
• FDA Update on How Science Shapes the Agency’s Regulatory Decision Making
• Applying Risk Management in a Straightforward Manner
• Best Practices in Trending QSR Data
• Integrating End-Use Communities into Device Design Workflow
• CDRH’s Compliance and Enforcement Outlook
• Best Practices in FDA 483 and Warning Letter Management and Recovery
• The 510K Overhaul and What It Means for Quality Professionals
• FDA’s Expectations for Postmarket Surveillance and Signal Detection
• Recall Management—Lessons Learned

Preconference workshop

“Writing for Compliance: Approaches and Methods for Writing High-Impact, Persuasive Compliance-Related Documentation within FDA-Regulated Companies,” will be conducted by John C. Garvey, founder and principal of Compliance Architects. Harvey has developed an introductory workshop to help participants apply a collection of writing tools to achieve improved compliance outcomes within FDA-regulated companies. Participants will understand:

• The first question to ask and answer before you engage in a writing activity
• How to analyze audience(s) to obtain the proper tone and voice for the writing
• What one basic writing structure should be applied to all CAPA investigations
• Which styles are necessary for different document types, including which should be the dominant style and how and where to include other styles
• The principle that lawyers apply to create powerful persuasive writing regardless of the soundness of their case
• What is the role of technical information within a document, and how should this information be presented?

In addition, given the importance the FDA places on CAPA, Garvey will spend considerable time on techniques and approaches for improving the documentation of CAPAs, nonconformances, and other investigation and product-analysis events.

Register here.


About The Author

FDAnews’s picture


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.