Industry Reluctant To Join Regulatory Harmonization Pilots
This article was originally published in The Gray Sheet
Executive Summary
Global harmonization of manufacturing quality inspections could move forward if firms would agree to try new approaches, FDA maintains, but industry worries that taking that leap could bring risks
You may also be interested in...
GMP Inspection Results Can No Longer Stay Within Borders, Says FDA
Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, FDA officer and chair of the Global Harmonization Task Force
GMP Inspection Results Can No Longer Stay Within Borders, Says FDA
Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, FDA officer and chair of the Global Harmonization Task Force
Global Accreditation Program For Auditors Could Be Ready In Two Years – IAF
A global accreditation program for conformity assessment bodies that audit manufacturing quality systems is under development and could eventually improve access to medical technologies in countries just beginning to regulate medical devices