Designing and Establishing a Quality System for the Development and Manufacture of Cellular Therapy and Tissue Based Combination Products

  • Background: technical requirements, standards, compendial and regulatory requirements for cellular and tissue-based combination products
  • Evolution and current state of quality regulations pertaining to cellular and tissue based combination products; applicability
  • CGMP, QSR, GTP, and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development of cellular and tissue-based combination products, development and purchasing relationships, requirements, vendor controls
  • Streamlined, linked and isolated quality systems
  • Compliance and inspections