Although quality management is relatively new to cellular therapy programs and cord blood banks, the principles of quality assurance and quality control have long been incorporated. For the FACT accreditation process, the real turning point for emphasis on quality management activities was with the release of the third editions of the Cellular Therapy Standards and Cord Blood Standards which included greatly expanded Quality Management sections. Since that time, FACT has developed and introduced quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program.
The intent of this Handbook is to provide practical advice and examples from Quality experts in the cellular therapy and cord blood bank communities. The Quality Handbook provides fundamental information about quality systems including chapters on Document Control Elements, Outcome Analysis, and Validation and Verification of Critical Procedures.