The FACT Quality Handbook, Third Edition is a comprehensive resource supporting quality management across FACT‑accredited programs. This edition introduces three new chapters: Root Cause Analysis, Good Documentation Practices, and Preparing for an Inspection. Each chapter features citation examples, required responses, and real‑world examples to assist with implementation of quality processes. With more than 60 new examples and a new glossary of terminology, definitions, and abbreviations, this edition is a valuable tool for strengthening program quality, supporting accreditation readiness, and advancing continuous improvement.
Quality Management Education
These quality events are designed for all personnel, with particular relevance for those involved in quality-related roles and initiatives. Browse the sessions below, and visit FACT's Learning Academy to access recordings of past series or register for upcoming offerings.
Quality Management Webinar Series
Each series is thoughtfully curated around specific themes to support quality management activities, ongoing education, and accreditation compliance.
NEW! QM Series 14: Occurrence Management: Closing the Loop Through Teamwork (2026)
QM Series 13: Building Stronger Quality Management Teams (2025)
QM Series 12, Part 1: Embrace Change: Growing Your Cellular Therapy Services (2023)
QM Series 12, Part 2: Embrace Change: Growing Your Cellular Therapy Services (2024)
QM Series 11: Corrective Action Plans (2022)
QM Series 10: Validation (2020)
QM Series 9: Auditing (2019)
QM Series 8: Document Control (2017)
QM Series 7: Outcome Analysis (2016)
QM Series 6: The Quality Organization (2015)
QM Series 5: Quality Management of Facilities (2014)
QM Series 4: Personnel (2013)
QM Series 3: Reporting QM Information (2011)
QM Series 2: Quality Assessment Activities (2010)
QM Series 1: Administrative Aspects of QM (2009)
Quality Boot Camps
Each year FACT hosts an in-person Quality Boot Camp with a theme focused on exploring key quality topics. These engaging events offer valuable opportunities to expand your perspectives, connect with peers, and participate in interactive roundtable sessions throughout the day. Can’t make it in person? Join our virtual boot camp, which features the same theme and collaborative roundtable experience. You can also explore recordings of past virtual sessions to continue learning anytime.
NEW! September 10, 2026 - Using a Risk Management Framework to Design Effective Validation Plans, Audits, and Corrective & Preventive Actions
2025 - Continuous Quality Transformation using Results of Audits and Outcome Analysis
2024 - Process Validations
2023 - Strengthen your Quality Management Program through the Effective Use of Quality Tools
Resources:
American Society for Quality (ASQ) - https://asq.org/
International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) - https://www.ich.org/
Quality Guidelines - https://www.ich.org/page/quality-guidelines
International Organization for Standardization (ISO) - https://www.iso.org/home.html
Institute for Healthcare Improvement - https://www.ihi.org/
National Association for Healthcare Quality (NAHQ) - https://nahq.org/
Oncology Nursing Society (ONS) - https://www.ons.org/
TCT Quality Roundtable Group is open to all TCT program and cord blood bank healthcare professionals with an interest in sharing information and practices around quality and performance improvement, accreditation, and/or regulatory compliance - https://groups.google.com/g/bmt-quality-roundtable/about?pli=1
U.S. Food and Drug Administration (FDA) - https://www.fda.gov/
Code of Federal Regulations (CFR) -
Part 1271-Human Cells, Tissues, and Cellular and Tissue-Based Products - https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General - https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals - https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
Guidance for Industry - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidances
