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Integration of Risk Management Principles and Activities into the Quality System

 
  February 11, 2016  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
April 18 & 19, 2016


The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry.  Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed

New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with Quality Management Systems re-build confidence for the three major stakeholder groups: Regulators, Industry and most importantly the Medical Community - including users & patients.

This course will cover Risk Management principals associated standards and practices together with how to develop, apply and implement strategies that reduce risks in the areas of drugs, devices and IVDs while working within established Quality Management Systems.

Topics covered include:

  • Current US and international regulatory requirements
  • Review & application of International Council for Harmonization Q8, Q9, Q10
  • Consideration of ISO 14971 and IMDRF (previously Global Harmonization Task Force) Medical Device Risk Management principals within a QMS
  • Risk Based approach for assessment of In Vitro Diagnostic

The course will identify the close link between Risk Management and QMS elements such as: Design Controls, Corrective and Preventive Action, Supplier Management, Change Control, Complaint Handling, and Production and Process Control

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience.

Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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