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FDA Compliance

Event: 7th Annual Medical Device Quality Congress

From risk management to postmarket surveillance

Published: Wednesday, March 31, 2010 - 14:15

(FDANews: Falls Church, VA) -- FDAnews has announced details for its 7th Annual Medical Device Quality Congress to be held June 2–4 in Bethesda, Maryland.

Changes affecting medical device firms in 2010

The year 2010 has begun with a bang. A new director at the Center for Devices and Radiological Health (CDRH), changes in recall requirements under the “corrective fix” pilot program, upcoming postmarket surveillance initiatives, the difficult 15-day deadline for responding to 483s, steps to improve the quality of clinical data that support premarket approval applications, revisions to the 510(k) clearance process, and more.

With a start to the year like this, what will the rest of 2010 hold for medical device companies?

That’s not easily or quickly answered—but there are experienced experts and top-ranking FDA officials to contact for keeping in-the-know and up-to-date on all the critical issues that may concern you and your company this year, going right through to Dec. 31.

To tap into this incredible knowledge base, attend the 7th Annual Medical Device Quality Congress, which will feature more than 15 in-depth sessions headed up by leading quality experts, including sessions led by three CDRH officials.

This program has been prepared with specific concerns in mind. The exclusive FDAnews survey of device-makers pinpointed “Top 5” most important quality issues—risk management, design control, supplier quality, quality systems regulation compliance, and postmarket surveillance—and this conference’s program is built around them. Get answers to the toughest questions like the following, and many more:

  • How will the CDRH pressure firms to improve quality assurance and engineering principles?
  • What about “sister suppliers” and regulations surrounding supplier management?
  • What new problems are field investigators uncovering?
  • How will the Unique Device Identifier (UDI) system and the Sentinel Initiative affect postmarket surveillance in your company?
  • What’s up the CDRH’s sleeve for 2010 and beyond?


Throughout two and a half days of laser-focused sessions and interactive panels, you’ll hear from many of the industry’s top quality experts from companies large and small, including Philips Healthcare, Boston Scientific, Becton, Dickinson & Co., Genentech, and others.

Sessions include:

  • CDRH Outlook
  • Minimizing the Risk in Risk Management: Understanding and Living ISO 14971:2009
  • CDRH Update on Design Control: Improving Quality Assurance and Engineering Principles
  • Tools for Efficient Design Control: Best Practices for Lowering Costs and Improving Schedules While Remaining Compliant
  • Understanding Internal and External Supplier Relationships
  • Forget About Controlling Your Suppliers: You Can’t
  • Creating a Supplier Management Program
  • Managing Operations Effectively: Deliver Quality Devices and Always Be Audit-Ready
  • Ensuring Valid Results: Test Method Validation
  • Closing the Loop on Corrective and Preventive Action (CAPA): A Call to Action
  • Japan and China Quality Management Systems
  • Understanding Post-Marketing Surveillance Expectations
  • Understanding Medical Device Reports Under 21 CFR Part 803
  • Medical Device Recalls: Unique Challenges and Opportunities


Preconference workshop

“Reducing Human Error on the Manufacturing Floor” with Ginette Collazo, founder and CEO of Ginette M. Collazo Inc.

Discover ways to implement proven and measurably successful human reliability and error reduction initiatives. Attendees will learn how to influence human factors to assure CAPA compliance and reduce errors. Collazo will also reveal tips and tricks for writing accurate job descriptions, innovative hiring practices, and how to develop great SOPs.

Human error is still one of the most commonly cited causes of failures and recalls. The vast majority of CAPA investigations conclude with some kind of human error as the root cause.  Collazo will share more than 10 years of in-depth research and experiences helping medical product firms reduce errors by up to 50 percent.

Conference co-chairs

Barry Craner is director of design assurance for Boston Scientific Corp., past chair of the ASQ Biomedical Division, and is past co-chair of the ASQ Biomedical Division’s Northern California Discussion Group. He is in his sixth year teaching on risk management. Craner has more than 30 years of experience in the management of scientists and engineers in applications in medicine, aerospace, internet technologies, and medical devices. He has written several design control systems for companies and has consulted in areas of reliability engineering, risk management, design control, and quality system development. He has audited many medical device companies from first-, second-, and third-party perspectives. His advanced degrees are in cardiac physiology, and business management with a computer information systems emphasis; and he has the equivalent of an electrical engineering minor.

Edwin Bills is the principal consultant at Bilanx Consulting. During his 22-year career in medical devices, Bills has held a number of quality and regulatory affairs positions. He is ASQ-certified as a quality engineer, quality auditor, and as a manager of quality/organizational improvement. He also holds a certificate as regulatory affairs-certified through the Regulatory Affairs Professionals Society. He has a bachelor’s and a master’s degree from the University of Cincinnati. Recently, Bills served as U.S. industry co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices, and participated in the development of the risk management standard for medical devices, ISO 14971. He is a current member of the U.S. national committee on medical device risk management and also the U.S. national committee on medical device quality management systems.

Who should attend?

  • Executive management
  • Regulatory affairs
  • Quality assurance/quality control
  • Research and development 
  • Training directors
  • Compliance officers
  • Manufacturing and contracting
  • Release management
  • Consultants/service providers


When and where?

7th Annual Medical Device Quality Congress
June 2–4, Bethesda, Maryland
Bethesda North Marriott Hotel & Convention Center

Early-bird rate through April 30:
Complete congress (includes conference and workshop): $1,697 per attendee
Conference only: $1,497 per attendee
Preconference workshop only: $537 per attendee

Regular rate May 1-June 2:
Complete congress (includes conference and workshop): $1,997 per attendee
Conference only: $1,697 per attendee
Preconference workshop only: $597 per attendee


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.