FDAnews has announced their 7th Annual Medical Device Quality Congress: From Risk Management to Postmarket Surveillance to be held June 2-4, 2010, in Bethesda, MD, USA.
Information from their website:
2010 has begun with a bang. A new director at CDRH … changes in recall requirements under the “corrective fix” pilot program … upcoming post-market surveillance initiatives … the difficult 15-day deadline for responding to 483s … steps to improve the quality of clinical data that support PMA 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 who can keep you in-the-know and up-to-date on all the critical issues that will concern you and your company this year, going right through to Dec. 31.
But how do you tap in to this incredible knowledge base?
By attending 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 3 CDRH officials.
This program has been prepared with you in mind. The FDAnews survey of device-makers pinpointed your “Top 5” most important quality issues — risk management, design control, supplier quality, QSR compliance and postmarket surveillance — and this conference’s program is built around them. Attend and you’ll get answers to your toughest questions like these, and many more:
* How will the CDRH pressure your firm to improve QA 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 post-market surveillance in your company?
* And … what’s up the CDRH’s sleeve for 2010 — and beyond?
And that’s just the beginning. During 2½-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.
The 7th Annual Medical Device Quality Congress 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
Pre-Conference Workshop:
Reducing Human Error on the Manufacturing Floor
Ginette Collazo, Founder & CEO, 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. Dr. Ginette 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. Dr. Collazo will share more than 10 years of in-depth research and experiences helping medical product firms reduce errors by up to 50%.
Who Should Attend:
* Executive management
* Regulatory affairs
* Quality Assurance/quality control
* R&D
* Training directors
* Compliance officers
* Manufacturing and contracting
* Release management
* Consultants/service providers
When & Where:
7th Annual Medical Device Quality Congress
June 2-4 2010; Bethesda MD
Bethesda North Marriott Hotel & Convention Center
Tuition:
Early Bird Rate Through April 30 2010:
Complete Congress (Includes Conference and Workshop) $1,697 per attendee
Conference Only $1,497 per attendee
Pre-Conference Workshop Only $537 per attendee
Regular Rate May 1-June 2 2010:
Complete Congress (Includes Conference and Workshop) $1,997 per attendee
Conference Only $1,697 per attendee
Pre-Conference Workshop Only $597 per attendee
4 Easy Ways to Register:
Online: http://www.mdqc2010.com/
By phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to:
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
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.
For more information, please visit the FDAnews website.
