Designing and Establishing a Quality System for the Development and Manufacture of a Drug (and Biologic) Delivery System

  • 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, 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
  • CGMP, QSR, GTP and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development paradigms for drug delivery devices and systems, development and purchasing relationships, requirements, vendor controls
  • Streamlined, linked, isolated quality systems
  • Compliance and inspections