FACT Cellular Therapy Collection Workshop at 2019 Annual ASFA Meeting
May 15, 2019
Join FACT on Wednesday, May 15, at the Hilton Portland Downtown in Portland, OR, for a workshop designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities.
FACT representatives will be in attendance to discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.
FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:
• Blood and marrow transplant (BMT) programs
• Cord blood banks
• Cell processing laboratories
• Physicians, scientists, and principal investigators
• Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
• Quality managers
The day includes a general track for attendees with separate breakout sessions for cellular therapy and cord blood participants. Inspector trainees are required to attend the inspector orientation track.
ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Is your cell processing facility FACT accredited or looking to comply with FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.
Focused on issues identified by FACT-compliant transplant programs, these sessions will include activities and discussion in Document Control, Incorporating IECs into your Quality Plan, Performing Risk Assessment: Real Life Applications, Process Validation, and Evaluating and Reporting Audit Results. Come prepared with your quality program questions and leverage quality experts to identify process improvement opportunities you can apply at your organization.
FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:
• Overview of FACT Accreditation Processes
• Common Citations Overview
• Building Quality into Clinical Immune Effector Cell Therapy Programs
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Improving Data Management Through Follow-Up
• FACT Process for Reviewing Clinical Outcomes
New Webinar Announced in Quality Management Series 9: Auditing
The Quality Management Series Module 9 includes four sessions focused on auditing. The first session, Auditing: Planning and Executing, was held on January 23, 2019. Leigh Poston, BMT Program Quality Management Coordinator at UF Health Shands Hospital, discussed designing audit strategies, identifying specific audits to perform, creating an audit schedule, determining the scope of the audit, and executing the audit. View on-demand webinar
The second session, Auditing: Summarizing and Evaluating the Data, was live on March 6, 2019. Ed Brindle MSc, MLT, Quality Manager at UHN Blood and Marrow Transplant Program, discussed writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. View on-demand webinar
The third webinar in the QM series 9: Audits, titled Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors, will be on June 11, 2019 at 11:00 am ET. Gordana Svajger, Quality Compliance Program Manager at The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program, will identify methods for verification of corrective actions, interpret when corrective actions are effective, and determine when to close an audit. View webinar details and register
The last session in the series will be, A Program’s Perspective: Auditing. The date and time will be announced when determined.
Register for the entire module to receive a 15% discount! QM Series Module 9: Auditing
WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the 2019 WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 12, 2019, in conjunction with the Cord Blood Connect International Congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight recent advances in cord blood transplantation and include global perspectives of cord blood transplants, common FACT-NetCord inspection citations, and more. The afternoon consists of two breakout sessions: a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Registration fees are waived for FACT active and trainee inspectors. Apply to be a FACT inspector!
FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.