Quality Systems Regulations (QSR)

The course will present and assist understanding of the differences between the US and European medical device standards.

Who should attend?
The course has been designed for staff in the medical device industry who need to gain insight into FDA QSR/GMPs and people about to take part in planned FDA inspections. It is a benefit to have some familiarity with QSR and ISO 13485 before the course.
 
 
Course content

The course will present and assist understanding of the differences between the US and European medical device standards.
 
This will include a review of FDA Quality System Regulations and comparison with the ISO 13485 standard. 
 
In addition, focus will be on FDA inspections, illustrated by means of case studies based on results of FDA inspections.
 
The following subjects will be presented and discussed:

  • Background of the U.S. FDA regulations
  • Preparing and surviving to a FDA inspection: the FDA QSIT Guidance and other useful guidance documents
  •  The USA FDA QSR and comparison with ISO 13485:2003
  • QSR: From Subpart A to Subpart O, including discussion of the USA FDA Medical Device Reporting (MDR) and Corrections and Removals Regulations
  • Examples of FDA Warning Letter for each subpart of the regulation

Course form
The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.

"Very dedicated speakers, that knew the subjects in details. Were able to bring in a lot of 'hands on' experience."Participant, Spring 2013

 

Det er ikke muligt at tilmelde sig dette arrangement i øjeblikket

Kontakt

Morten Petersen
Kursuskoordinator
49184703