Save hours of work reviewing existing SOPs, crafting new processes, and training personnel by taking advantage of the information in this edition of the FACT Quality Handbook. This handbook is meant as a guide to understanding, learning, and applying core quality principles to the cellular therapy organization whether it be a clinical program, collection facility, processing laboratory, or cord blood bank.  While the handbook is geared toward the Quality professional, all personnel involved in a cellular therapy organization will benefit from the handbook and gain an understanding on how their area can apply these quality fundamentals. 

The first chapter of the handbook provides an overview of the quality management program and the role of a quality plan.  The remaining twelve chapters provide details on a specific quality topic such as Document Control Elements, Outcome Analysis, and Deviations Management.  Throughout the chapters, examples or scenarios are provided to show how organizations have approached a quality concept.  Also provided are common deficiencies noted in past inspections and their corrective actions. Download the Quality Handbook, Second Edition



FACT Consulting

Accreditation Success Story

Hoxworth Blood Center Apheresis Collection Facility and its Cellular Therapies Division have been accredited by FACT since 2003. The program values their FACT accreditation and the impact it has had on their program’s continuous quality improvement objectives. Read more