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Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency

 
  August 22, 2013  
     
 


ComplianceOnline, United States
2013-09-09


Course Description:

FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive one and a half day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.

It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.

Learning Objectives:

  • To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
  • To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
  • To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
  • To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
  • To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
  • To provide attendees with the Dos and Don'ts for an effective and efficient risk management system

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

 

Fubin Wu
Co-Founder & Chief Solution Architect at GessNet

Fubin Wu is the Co-Founder of GessNet. He architected and led the development of TurboAC, risk management & safety assurance case software, in close communications with FDA, Office of Science & Engineering Lab (OSEL) and Office of Device Evaluation (ODE), and in close collaboration with medical device manufacturers, hospitals, AAMI (Association for the Advancement of Medical Instrumentation), and industry experts. Prior to his full-time role as the Chief Solution Architect at GessNet, Fubin has spent over 16 years on medical device quality management systems, hardware/software reliability engineering and risk management, serving various roles from quality engineers to quality managers and quality directors, and working on various medical device platforms – implantable devices at Medtronic, infusion pumps at Hospira, and blood management systems at Haemonetics. He managed numerous FDA inspections as the management representative with no 483 observations indicated.

 

 
Deadline for Abstracts: 2013-09-08
 
Registration: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80076SEM&?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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