NPG QMSR Webinar
NPG’s Senior Director of Quality, Marnie Smith, hosts a webinar on Quality Management System Regulation (QMSR) changes and how the FDA’s recognition of the similarities of ISO 13485 and 21 CFR Part 820.
Highlighted topics of this webinar include, but are not limited to:
- The FDA’s ruling on the Quality System Regulation (QSR) to Quality Management System Regulation (QMSR) transition
- The transition to ISO 13485 and the new QMSR
- Changes in terminology and adoption of ISO 13485 terms in QMSR. DHF, DMR, and DHR will be replaced with DDF, MDF, and batch records
- Changes in FDA inspections and how they will now allow management reviews and internal audit records to be audited
- And much more
