Just the FACTS, 2020 Volume 1
I am looking forward to seeing everyone at the Tandem, oops!, TCT meetings—some of us take longer to train than others . . . Lots of changes and new events, including a “Mingle with Mimosas” on Thursday for all inspectors to recognize our volunteer force while enjoying a continental breakfast . . . and mimosas! Thank you to everyone for all of your volunteer time, and for everyone else, please consider becoming an inspector. There are more personal and professional benefits from doing inspections than you can imagine.
Once again we are offering leadership training courses, both the original and now advanced courses and of course the Inspection and Accreditation Workshop on Tuesday with a new format. To attend the inspector track you must be pre-approved by the FACT office to be eligible to be an inspector, so register ahead. The Quality Boot Camp session will be on Wednesday to round out 24 full hours of FACT training opportunities at the TCT meeting.
Be sure to pay attention to the online educational offerings, particularly the new Immune Effector Cell Therapy Webinar series, 6 webinars in 2020 by colleague experts in the field.
Last, but certainly not least, remember the FACT Cord Blood Inspection and Accreditation Workshop at the ISCT Annual Meeting in Paris—if that location doesn’t get you there, nothing will. Again, if approved by the office as eligible to be a trainee, that course is free of charge.
Whew! So much to do in Florida, you may not need to bring sunscreen! See you all there!
Sincerely,
Dennis Gastineau
FACT President
Recently Published Book Includes Chapter on FACT Citations in Apheresis
The recently published book, Best Practices of Apheresis in Hematopoietic Cell Transplantation (Abutalib et. al., 2020), includes a large number of topics relating to the use and performance of apheresis in hematopoietic cell transplantation. The book is described as a practical resource for clinicians ranging from residents to faculty members and other healthcare personnel. The book is available for purchase in its entirety or by individual chapters.
FACT President Dennis Gastineau, MD wrote Chapter Three, FACT-JACIE Standards: Common Citations and How Best to Avoid Them. The chapter on citations focuses on deficiencies found in apheresis facilities during on-site FACT inspections. Dr. Gastineau briefly describes the citations and then suggests methods for avoiding them in future inspections.
Abutalib, S.A., Padmanabhan, A., Pham, H.P., Worel, N. (Eds.) (2020). Best Practices of Apheresis in Hematopoietic Cell Transplantation. Springer International Publishing. doi: 10.1007/978-3-319-55131-9.
Develop Essential Leadership Skills with FACT Courses at the 2020 TCT Meetings
Everyone wins when a leader gets better. Join FACT for Cellular Therapy Leadership Courses 101 and 201 on Tuesday, February 18, 2020, at the Orlando World Center Marriott from 8:00 am – 12:00 pm. Cellular Therapy Leadership 101 is a half-day course open to anyone who has (or aspires to) a leadership position. 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, this workshop is for you!
If you completed the Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you. This advanced course is offered on February 18, 2020, from 1:00 pm – 4:30 pm and drills deeper into leadership skills and organizational health.
Register for the FACT Leadership 101 course
Register for the FACT Advanced Leadership 201 course
FACT Exhibit Booth at TCT: Meet and Greet with Accreditation Services Leaders!
FACT invites you to visit exhibit booth 733 to meet the leaders of Accreditation Services and have your accreditation and standards questions answered!
On Thursday, February 20, FACT Accreditation Supervisor, Sarah Litel-Smith, will be available at the FACT exhibit booth from 12:00 pm – 2:00 pm
On Friday, February 21, FACT Accreditation Manager, Suzanne Birnley, will be available from 7:00 am – 9:00 am.
FACT Inspectors Invited to Attend Mingle and Mimosas Networking Event at TCT
Thursday, February 20, 2020
7:00 am – 8:30 am
FACT invites its inspectors to mingle with colleagues while enjoying a continental breakfast and morning mimosa! We want to take this opportunity to thank all our volunteers for their continued dedication and time devoted to FACT. We hope you can join us for a morning toast to you!
FACT Announces Immune Effector Cellular Therapy Webinar Series
The FACT Education Committee and Immune Effector Cell Task Force have developed a series of webinars on Immune Effector Cellular Therapy. Six webinars are planned throughout 2020 and include the following topics:
The State of FACT Immune Effector Cell Therapy Accreditation Today presented by Dr. Patrick Hanley
Wednesday, March 4, 2020
11:00 am ET, 16:00 GMT
Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children’s National Health System Blood and Marrow Transplant Program, will present the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley will discuss the growth and expected direction of IEC Accreditation and describe the major concepts addressed the FACT IEC Standards. He will also explain various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.
Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT
Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.
Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT
Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy. He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.
Other sessions within this series include:
- Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance (Date/time TBD)
- IEC Inspector Training (Date/time TBD)
- Data Reporting and REMS Compliance (Date/time TBD)
Final Webinar in the Quality Management Series, Auditing
February 5, 2020
3:00 pm ET, 20:00 GMT
Join FACT for the final webinar in the ninth Quality Management Series, Auditing. Phillip Johnson, MMedSc(Path), Production Manager at Queensland Cord Blood Bank at the Mater, Sylvia Dulan, RN, MSN, MBA, PMP, HCT Regulatory and Quality Management Specialist at City of Hope Hematopoietic Cell Transplantation Program, and Ann Wilson, MHA, MT(ASCP)SB , Lab and Quality Manager at Scott & White Autologous Transplant Program, will give an overview of their program’s audit process and how they write audit reports.
The first three webinars within the module are available for download in the FACT store:
- QM Series 9: Auditing: Planning and Executing
- QM Series 9: Auditing: Summarizing and Evaluating the Data
- QM Series 9: Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors
Stay tuned for the next QM Series 10, Validations! Topics include Validation Overview, Process Validation, Software Validation, and Program Perspectives on Validation.
FDA Announces Public Workshop on End-to-End Development of Individualized Therapeutics
The United States Food and Drug Administration (FDA) announced a public workshop titled, “Facilitating End-to-End Development of Individualized Therapeutics,” focusing on development of individualized therapeutic products for one or a small number of patients. This workshop will be on March 3, 2020 from 8:30 am to 5:00 pm ET, and can be attended in person or via webcast. Registration is required.
Per the FDA announcement, the objectives of the workshop are:
- “To discuss scientific challenges to development of individualized therapeutics, and ongoing efforts to adapt products manufactured based on a technology platform to treat diseases affecting one individual or a very small number of patients; explore lessons learned, logistical challenges, failures, and successes.
- To examine challenges under the current U.S. regulatory framework that need to be addressed to have a clear pathway for access to individualized therapeutics, including licensed manufacture and consistent delivery of safe and effective products.
- To explore challenges from the patient perspective that limit development and access to individualized therapeutics; consider research and development, ethical, and product availability and access issues.
- To identify new models of collaboration or synergies that may facilitate aspects of development, including manufacturing, preclinical testing, clinical development, and continuing evaluation for consistent production, availability, and delivery of individualized therapeutic products.”
For more details and to register, see the FDA announcement.
FACT Education Events
We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!
FACT Cellular Therapy Inspection & Accreditation Workshop
February 18, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the FACT-JACIE Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.
The workshop includes two tracks: Applicant training and inspector training. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.
Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!
Register for the FACT workshop
FACT-ASTCT Cellular Therapy Quality Boot Camp
February 19, 2020
8:00 am – 5:00 pm
Join us for a day focused on core quality concepts. The sessions will include quality processes programs have implemented and incorporating Immune Effector Cells into all parts of your quality program. A self-assessment will be distributed prior to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Complete the self-assessment, join the roundtable discussions, participate in the activities, and leverage QA experts for ideas on how to take your program’s quality program to the next level.
Register for the FACT-ASTCT Quality Boot Camp
FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 20, 2020
5:00 pm – 7:00 pm
The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT & CIBMTR to be held in Orlando, FL at the Orlando World Center Marriott on Thursday, February 20, 2020, 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 in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. This 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.
Register for the FACT Global Affairs session
FACT Cord Blood Inspection & Accreditation Workshop
May 26, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the FACT accreditation requirements. FACT representatives will clarify the intent of the NetCord-FACT Standards and assist programs in organizing and preparing for the accreditation process. In addition, individuals interested in becoming a FACT inspector are encouraged to attend inspector training.
The workshop includes two tracks: Applicant training and inspector training. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. In order to attend this track, you must be pre-approved as an inspector trainee. This track is designed to guide the trainee through the inspection experience; from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee will receive an inspection checklist accompanied by applicable inspection documents.
Interested in becoming a FACT Inspector? Apply to train as an inspector. If eligible, trainees attend free of charge!
Register for the FACT workshop
FACT Cord Blood Inspection & Accreditation Workshop
September 9, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.
Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the applicant and inspector training track!
