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 the U.S. FDA QSR and ISO 13485 before the course.
Course content
The course is based on the ISO 13485:2016 edition and selected country-specific requirements for the USA from the Medical Device Single Audit Program (MDSAP).
In addition, focus will be on FDA inspections, illustrated by means of case studies based on results of FDA inspections (Warning Letters).

The following subjects will be presented and discussed:

  • QSR general aspects and FDA inspection program
  • QSR, Subpart A
  • MDSAP Country-specific requirements for USA
  • Additional U.S. regulations from 21 CFR 1000-1050 and 21 CFR 4

Course form
The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.
Enzo Passalia, Quality Systems and Regulatory Specialist, DONAWA LIFESCIENCE CONSULTING Srl, Rome Italy

"Really liked it covered the subject thoroughly while using relevant examples"

"Very useful information about where to find additional webinars etc. on the FDA website"

Participants, Fall 2019


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mp@medicoindustrien.dks billede
Morten Petersen