UL is pleased to let you know about an important series of seminars offering expert panels addressing the global issues in medical device quality and compliance you face every day.   As a UL Health Sciences subscriber, we are pleased to share with you a 10% discount on these seminars when you register with discount code "SSUL".

 

On March 29-31, 2011 in Baltimore, Maryland, Certified Compliance Solutions, in cooperation with UL, AMDM, and FOI Services, will host three seminars presented by a distinguished faculty of FDA and industry speakers...and you can register for one, two, or all three of these timely, issue-packed and technology-heavy sessions:

 

March 29: The Latest Techniques for Improving Product Safety
March 30: Agile and Risk-Based Approaches for Design Controls
March 31: Harmonizing Global Quality Systems to Reduce Compliance Risks

 

FDA speakers include:

• John Murray, Software Compliance Expert
• Kim Trautman, Quality Systems Expert
• Larry Spears, Deputy Director, Office of Compliance

Industry speakers include:

·  Chuck Weinstock, SEI Carnegie Mellon

·  Dan Olivier, Certified Compliance Solutions

·  Ed Israelski, Abbott and co-chair, AAMI's Human Factors Engineering Committee

·  Javad Seyedzadeh, Gambro

·  Jeff Dere, Life Technologies

·  Tracey Holevas, GE Medical

·  Shelley Looby, Cerner Corp.

·  Stan Mastrangelo, Virginia Tech

·  Teresa O'Shea, Ethicon Endo-Surgery

·  Will Stubblebine, Bio-Rad Laboratories

·  Lesley Traver, ITC Nexus Dx

 

March 29: The Latest Techniques for Improving Product Safety

• How emphasizing human factors analysis can enhance product safety
• How to make an assurance case to show that safety claims for a device are valid
• How GE Medical is implementing an effective risk management process
• Do's and don'ts for complaints, failures and MDR reporting
• Lessons learned about safety risk management after 10 years of ISO 14971
• How to use safety risk management in preventive action

March 30: Agile and Risk-Based Approaches for Design Controls

 

• Using product safety and IEC 62304 to guide software development
• Dos and don'ts for using agile methods
• Workshop: Experiences with Agile
• Risk-Based Compliance - Negotiating Pathways to Innovation
• First public presentation on the new AAMI TIR on agile methods for medical devices
• Understanding the key elements of Agile requirements definition

March 31: Harmonizing Global Quality Systems to Reduce Compliance Risks

• Keys to establishing a harmonized quality system
• Techniques for maintaining a global quality system with minimal resources
• How is FDA continuing its harmonization work with GHTF, TC 176 and TC 210
• How to manage a critical regulatory inspection
• How to use metrics to drive common quality improvement goals

Registration:

Special pricing for early registration is available until March 15: One day is $595; any two days is $1095; register for all three days for $1395.   *Special for UL Health Sciences Subscribers - enter discount code "SSUL" for 10% off*

 

To register, click here and fill in your name, company, phone and email address. After you click 'Submit', select the days you will attend and continue on to your cart.

 

 

 

 For more information on how UL can help you with global market access, visit our web pages at www.ul.com/medical or find your local UL office at:  www.ul.com/contact .