home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops
Search  -  prev / next
 
 

Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)?

 
  January 30, 2019  
     
 


ComplianceOnline, Singapore
2019-03-20


This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.

 

Learning Objectives:

  • What is the Medical Device Single Audit Program (MDSAP)?
  • Which Companies must have MDSAP?
  • Which Companies should have MDSAP?
  • Which Companies should postpone MDSAP?
  • What are the requirements of MDSAP?
  • How to implement MDSAP in a smart way into a quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
  • How the MDSAP-Audit is working?
  • What is the difference between MDSAP and European Notified Body Audits?

Who will Benefit:

Life sciences companies who sell to Australia, Brazil, Canada, Japan or US will be benefited by attending this seminar:

  • CEO and top executives
  • Regulatory Affairs Managers
  • Quality Managers
  • Quality Representatives
  • Other managers, who need to deal with regulatory or quality guidelines

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
 
Deadline for Abstracts: 2019-03-19
 
Registration: Please click here for registration information.
E-mail: referral@complianceonline.com
 
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995-2019 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.