Quality Auditing of Medicated Device Constituent Part and Component Part Manufactures

  • Preparatory training for CGMP compliance audits of medicated device component and constituent part co-development partners, manufacturers, vendors and/or, contractors
  • Background: anatomy, technical requirements, standards, compendial and regulatory requirements for a variety of medicated devices (viz., drug-coated stents, -catheters, -implants, -electrode leads) and systems; how they work, how are they used and how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to medicated devices and systems; applicability
  • Key CGMP requirements: calculation of yield, stability studies and expiration dating, drug substance testing and release for distribution, reserve samples
  • ICH guidelines
  • Collaborative development paradigm for medicated devices and systems
  • Sponsor and vendor relationships and responsibilities; development and purchasing relationships, requirements and vendor controls
  • Drug Master Files and Device Master Files
  • Compliance and Inspections
  • Audits