Cellular Therapy Inspection and Accreditation Workshop
FACT was excited to be a part of the ISCT North American Regional Meeting in Madison, Wisconsin. Participants joined FACT on September 12, 2019, for the FACT Cellular Therapy Accreditation and Inspection workshop. The workshop included individuals from the United States, Canada, and Australia.
Applicants discussed the challenges complying with FACT Standards and demonstrated how to overcome them; reviewed how to perform a risk assessment, practiced the use of the 5 Whys process, and evaluated the distribution of cellular therapy products. In addition, Dr. Jean Sanders presented about quality management in novel cell therapies.
Inspector Trainees participated in a separate training track in which they engaged in activities to effectively perform an inspection. Trainees worked with the inspection checklist and prepared comments noting noncompliance with standards, evaluated SOPs for training and competency, developed a plan for pre-inspection, and appraised unexpected issues that come up during an inspection along with proposed resolutions.
Sincere thanks to all of the participants, the invited speakers, the local organizers, and ISCT for their support.
ISCT-FACT Cellular Therapy Quality Boot Camp
Therese Dodd, Vice Chair of the FACT Quality Management Committee, welcomed the attendees and began the day with a presentation on “Assessing the Effectiveness of Your Quality Plan.” A roundtable session followed where scenarios were used to evaluate the effectiveness of the QM Plan. Federico Rodriguez discussed how the “Five Whys” can be used when evaluating occurrences, whether detected during an audit or when the occurrence is identified. One of the most popular presentations was “Integrating Risk Assessment into Your Quality Program” presented by Amy Beres and Jennifer Frank. The FACT Quality Management Committee acknowledged Aurora Health Care Autologous Stem Cell Transplant Program’s risk assessment process as a commendable practice. The attendees practiced using the risk assessment tools and over half indicated that they will incorporate this process at their program.
The afternoon began with “Supply Qualification” presented by Deborah Griffin and Emily Hopewell. A supply qualification assessment tool was provided and used during a hands-on exercise. A third of the attendees plan to update their supply qualification process with the information provided. Ed Brindle provided an interesting history of Document Control as it relates to the FACT-JACIE Hematopoietic Cellular Therapy Standards and how the UHN Blood and Marrow Transplant (BMT) Program is transitioning to an electronic document control system. The final presentation focused on planning audits and writing an audit report presented by Heather Conway, FACT-ISCT Data Audit Committee member. During the audit activity session attendees used ISBT’s Audit Tool, and discussed how the tool can be used in conjunction with FACT labeling requirements in an internal audit. The day ended with an opportunity to “Ask FACT” about issues, processes, and/or documents with a presenter of their choice. Thank you to the attendees and presenters for great discussions throughout the day!
FACT Exhibit Booth