Outcome
The course will start with the newly published Quality Management System Regulation (QMSR) that replaces the Quality System Regulation (QSR) and will continue with the US-specific regulations using the Medical Device Single Audit Program (MDSAP) as a guidance. The focus will be on FDA inspections, illustrated by means of case studies based on results of FDA inspections (Warning Letters).

Course content
The following subjects will be presented and discussed:

• Overview of the new Quality Management System Regulation (QMSR)
• FDA inspections
• MDSAP Country-specific requirements for USA
• Additional U.S. regulations from 21 CFR 1000-1050 and 21 CFR 4

The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.
 
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 an advantage to have some familiarity with the US FDA QMSR/QSR and ISO 13485 before the course.
 
Trainer
Enzo Passalia, Quality Systems and Regulatory Specialist, DONAWA LIFESCIENCE CONSULTING Srl, 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 2023