FDA PAT Inspection Teams Being Formed: Further Training Set For Fall
Executive Summary
FDA is assembling review/inspection teams to help evaluate upcoming industry submissions involving implementation of process analytical technologies in manufacturing
You may also be interested in...
PAT Guidance Will Draw From Existing Guidances On Electronic Records
FDA plans to draw from existing guidances issued by the agency's device center to clarify 21 CFR Part 11 electronic record/electronic signature requirements in its planned PAT guidance
PAT Guidance Will Draw From Existing Guidances On Electronic Records
FDA plans to draw from existing guidances issued by the agency's device center to clarify 21 CFR Part 11 electronic record/electronic signature requirements in its planned PAT guidance
GMP Dispute Resolution System Under Development By FDA; PAT Is Impetus
FDA is planning to create a dispute resolution system for manufacturing inspections