Exceptional Release of Commercial Cellular Therapy Products
January 30, 2019
Join FACT on January 30, 2019, at 11:00 am ET, 1600 GMT, for a webinar titled, Exceptional Release of Commercial Cellular Therapy Products. Autologous cellular therapy products can be irreplaceable, and exceptional release of nonconforming products may be necessary to the well-being of patients. FACT-accredited programs are increasingly using autologous products that are licensed by regulatory authorities, and sometimes these products do not meet specifications. In this webinar, presenters will discuss FACT requirements for exceptional release, and then share their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.
Webinar presenters include:
Dr. Phyllis I. Warkentin, Chief Medical Officer of FACT
Dr. Premal Lulla, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Dr. Elizabeth Shpall, MD Anderson Cord Blood Bank Medical Director, MD Anderson Cellular Therapy Transplant Program Director, and co-director of the MD Anderson CARTOX program.
Dr. Phillip McCarthy, of Roswell Park Comprehensive Cancer Center – Transplant and Cellular Therapy Program for Adult Inpatient, Outpatient, and Pediatric Outpatient Programs – John R. Oishei Children’s Hospital
Validation Principles and Protocols for Cellular Therapies
February 6, 2019
Join FACT for a webinar, Validation Principles and Protocols for Cellular Therapies, on Wednesday, February 6, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.
FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR
Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
• Overview of FACT Accreditation Processes
• Common Citations Overview
• Integration of Immune Effector Cells into Accreditation
• Using the Tracer Methodology to Assess Compliance with FACT Standards
• Risk Evaluation and Mitigation Strategies (REMS)
• How to prepare for and conduct inspections
• Data Management
• Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management, personnel, and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201
February 20, 2019
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
FACT-ASBMT Quality Boot Camp
February 20, 2019
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.
Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.
Visit FACT at Exhibit Booth 2254!
During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.
Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.
2019 TCT Exhibit Booth Hours:
Wednesday, February 20
7:00 a.m. – 2:00 p.m.
Thursday, February 21
7:00 a.m. – 2:00 p.m.
Friday, February 22
7:00 a.m. – 1:00 p.m.
Saturday, February 23
7:00 a.m. – 1:30 p.m.
QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
This webinar will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action. This is the second webinar in the QM Series 9: Audits.