Quality Auditing of Drug Delivery Device Constituent Part and Component Part Manufactures

  • Preparatory training for QSR compliance audits of drug delivery device component and constituent part co-development partners, manufacturers, vendors and/or contractors
  • Background: anatomy, technical requirements, standards compendial, regulatory requirements for prefilled syringes and single-use disposable, reusable, general use and specific use drug delivery systems (viz., injection-, pulmonary-, nasal- and transdermal-based; safety devices and other drug delivery devices and accessories); how they work, how are they used, how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to drug delivery devices and drug delivery systems; applicability
  • Key QSR requirements: Management Responsibility; Purchasing Controls, Change Controls, Design Controls, CAPA
  • ICH guidelines
  • Collaborative development paradigms for drug delivery devices and systems
  • Sponsor and vendor relationships and responsibilities; development and purchasing relationships, requirements, vendor controls
  • Drug and Device Master Files
  • Compliance and Inspections
  • Audits