EDUCATIONAL RECORDINGS (141)

The presenter in this webinar demonstrates how FACT inspectors review evidence submitted by applicant organizations, request additional information, indicate compliance or noncompliance with the Standards, and generate inspection reports.

This webinar was held on November 3, 2015, at 11:00 EST. The therapeutic indications for cord blood are expanding, and the public and private collection of cord blood in countries around the world has grown dramatically in the past two decades. Can that growth be sustained? What research is underway exploring novel uses for cord blood cells and birthing tissues that could dramatically impact the use of units that are preserved today and tomorrow in public and private banks? Several representatives of the newly created Cord Blood Association (CBA) discussed their first-hand involvement in clinical and laboratory research using and engineering cord blood for cellular therapies and in the emerging field of regenerative medicine signaling continued growth in cord blood banking and therapies.

The purpose of this webinar held on April 6, 2016, at 11:00 am ET, 3:00 pm GMT, was to train new personnel at accredited programs, and programs seeking initial accreditation, on the critical and key components of maintaining compliance with the FACT Standards and progressing through the accreditation process. Offered free of charge, this presentation helped programs in maintaining their FACT accreditation status throughout their current and future accreditation cycles. Dr. Dennis Gastineau, of the Mayo Clinic Blood and Marrow Transplant Program, and Dr. Robert Rifkin, of the Cellular Therapeutics Department at the Rocky Mountain Cancer Centers, described the importance of keeping up with FACT requirements and provided advice for completing the FACT accreditation process.

This webinar was held live on January 27, 2016, 11:00 am ET, 4:00 pm GMT. Dr. Etienne Baudoux of the Liège Cord Blood Bank, and President of the International NetCord Foundation, took a global look at import and export requirements.

This webinar was held on March 23, 2016, at 11:00 AM EDT. Dr. Sergio Querol, Medical Director at the Programa Concordia Banc de Sang i Teixits in Barcelona, Spain, gave an overview of public cord blood banking.

This webinar was held live on October 14, 2015, at 11:00 EDT. Lisa Cantwell, MHA, CPHQ, Quality Manager from St. David's South Austin Medical Center, and Diane Fournier, PhD, from Héma-Québec, described methods for assessing organizational performance and compliance with accreditation and quality requirements. This webinar was the second session in the Quality Management Series Module 6: The Quality Organization.

This webinar was live on September 30, 2015, at 11:00 EDT, and was free of charge. In this webinar participants heard from several of the association’s leaders about progress to date and plans for the months ahead addressing industry priorities of advocacy, market expansion, quality assurance, public and healthcare provider education, and research and development. The presenters included: Dr. Joanne Kurtzberg, President of the Cord Blood Association, Director of Carolinas Cord Blood Bank in Durham, NC Geoffrey Crouse, MBA/MPH, Vice President of the Cord Blood Association, Chief Executive Officer of Cord Blood Registry in San Francisco Gesine Koegler, PhD, Chair of Quality Standards Committee, Cord Blood Association, Director of Carreras Cord Blood Bank and GMP Facility at University of Deusseldorf Medical Center, Duesseldorf, Germany.

This webinar was held live on Wednesday, February 1, 2017, at 11:00 ET. Dr. Isabelle Riviere and Dr. Xiuyan Wang of the Michael G. Harris Cell Therapy and Cell Engineering Facility at Memorial Sloan Kettering Cancer Center, addressed CAR T cell products manufacturing and regulatory considerations as well as handling procedures in the context of academic centers.

This webinar was held on Wednesday, February 14, 2018, at 11:00 ET. The recent widespread and commercial use of immune effector cells has led to increased complexity in maintaining chain of custody. In cellular therapy's earliest days, the cell products were managed almost exclusively by the principal investigators themselves. Today, immune effector cells are managed by a team of collection facilities, commercial manufacturers, GMP-compliant laboratories, cell processing facilities, and couriers. Dr. Sarah Nikiforow of the Dana Farber Cancer Institute / Cell Manipulation Core Facility, Dr. Rayne Rouce of the Baylor College of Medicine, Stem Cell Transplant Program, Texas Children's Hospital and Houston Methodist Hospital, and Dr. Solveig Ericson, Executive Director of the CAR-T Program at Novartis Pharmaceuticals Corporation, discussed the importance of maintaining chain of custody for these personalized cellular therapy products, particularly commercialized cell therapy products.

This webinar explains FACT requirements regarding audits, from scheduling them to implementing corrective actions based upon their results.

This webinar was held live on November 9, 2016, at 11:00 AM ET. Debe Griffin, MS, ASQ CPGP, and John Carpenter, Quality Assurance Manager at Duke University Medical Cord Blood Bank, discussed how to find, utilize, and keep good quality managers.

This presentation discusses Cellular Therapy Collection Facility inspections

The first webinar in this two-part webinar series was on Thursday, July 25, 2019 at 11:00 am ET. Part one includes information from Dr. Rayne Rouce from Baylor College of Medicine, Texas Children's Hospital, and Houston Methodist Hospital, and Dr. Joseph Alvarnas from City of Hope, regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians addressed the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation is also be covered.

This presentation discusses the various components of a Quality Management Program with emphasis on the FACT-JACIE and NetCord-FACT requirements.

This webinar was held on March 22, 2017, at 11:00 AM ET. Phyllis Warkentin, MD, FACT Chief Medical Officer, outlined the internal outcome analyses required by FACT and provided tips for completing them. Understanding the rationale for these required analyses, and seeing examples from other programs and banks, will help accredited organizations understand and believe in the worthiness of these studies.

This webinar provides an overview of the United States Food and Drug Administration (FDA) requirements for cord blood licensure and investigational new drugs.

Afin de complémenter la mission éducative que s’est donnée l’organisme Save the Cord Foundation dans le cadre de la Journée Internationale du Sang de Cordon, FACT vous invite à assister à un webinaire en français d’une durée d’une heure le 14 novembre 2018 à 9 am (HNC), 10:00 am (HNE), 15:00 GMT, and 16:00 pm (HNEC). Le but du webinaire est de mieux comprendre les défis actuels et les opportunités d’avenir dans le domaine du sang de cordon. Les sujets présentés seront les suivants: • Introduction et contexte par le Dr Éliane Gluckman • Résumé du FACT Quality Bootcamp qui s’est tenu le 14 septembre 2018 en amont du Cord Blood Connect Congress par le Dr Étienne Baudoux • Points saillants de la première édition du Cord Blood Connect Congress qui s’est tenu les 15 et 16 septembre 2018 par le Dr Diane Fournier • Mai Duong, bénéficiaire d'une greffe de sang de cordon, discutera du lancement d'un projet international de sensibilisation au don de cellules souches.. Ce webinaire présenté en français sera accessible sans frais. FACT vous encourage aussi à vous joindre à une conférence virtuelle sur le sang de cordon présentée par Save the Cord Foundation le 15 Novembre 2018. Le programme comportera des présentations s’adressant à un large public sur les avancées récentes dans les traitements utilisant le sang de cordon par des chercheurs et transplanteurs de renommée internationale.

This presentation was held on Wednesday, March 14, 2018, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, described changes to the 7th edition Standards and provide examples for effective implementation.

This webinar provides information on how to establish a Quality Management Plan and use it to implement a Quality Management Program in a cellular therapy program or cord blood bank.

The FACT Education Committee, in conjunction with the Clinical Outcomes Improvement Committee, presented a webinar on June 12, 2019, at 3:00 pm ET, highlighting transplant programs that consistently exceed expected one-year survival rates as reported in the CIBMTR Transplant-Center Specific Survival Report. This webinar consisted of presentations from the Blood and Marrow Transplant Program at Northside Hospital, Vanderbilt University Medical Center, and the FACT inspectors who evaluated them during the most recent inspections. Program representatives discussed the following: 1) how the program analyzes and trends clinical outcomes including survival, 2) aspects of the program believed to contribute to consistently high one-year survival (e.g., processes, guidelines, education, and any other aspect), and 3) any examples of instances in which the program made adjustments after detecting declining survival rates for a given set of patients. The inspector from each program discussed his impression of the program and opinions on why the program consistently achieves high survival rates.

Dr. Adrian Gee discusses physical facility characteristics of facility design and also how procedural design, organization, and documentation are necessary to make the most of available space.

This webinar was held live on Wednesday, May 11, 2022. Olive Sturtevant MHP, MT(ASCP), SBB/SLS from the Cell Manipulation Core Facility at Dana-Farber Cancer Institute in Boston, and Dr. Priti Tewari from the Children's Cancer Hospital at the University of Texas M.D. Anderson Cancer Center, discussed the following: 1. Assessing the problem by determining why errors or issues are occurring 2. Guides such as the 5 whys, FMEA, and fishbone 3. Short-term action 4. Long-term action

This webinar offers an introduction to Immune Effector Cellular (IEC) Therapy for the treatment of solid tumors. Basem William, MD, MRCP, FACP from the OhioHealth Blood and Marrow Transplant and Cellular Therapy Program and Sarah Nikiforow, MD, PhD from the Dana-Farber Cancer Institute Cell Manipulation Core Facility in Boston discussed unique challenges and considerations in IEC manufacturing; listed subtypes of IECs in solid tumors including TILs, CAR-T cells, and TCRs, and examined the need for quality standards.

El Dr. Carlos Bachier, Presidente del FACT-JACIE Comité Internacional y Dr. Cesar Gutierrez del Universidad Autónoma de Nuevo León, Servicio de Hematología Hospital Universitario, presentarán una visión general de los estándares FACT-JACIE para la Recolección, Procesamiento y Administración de Productos Hematopoyéticos de Terapia Celular y la aplicación de estos estándares en Universidad Autónoma de Nuevo León respectivamente. El webinar concluirá con una sesión de preguntas y respuestas, en la que les animamos a participar para poder solventar cualquier duda sobre los estándares y su aplicación.

El webinar en el mes de diciembre fue presentado por Eugenia Trigoso Arjona, enfermera responsable del sistema de calidad en el Hospital Universitari i Politècnic La Fe de València, España. Este webinar analizado la importancia a las auditorías, desde la programación hasta la implementación de acciones correctivas basadas en sus resultados. La Sra. Arjona facilitó los requisitos de FACT-JACIE para auditorías y facilitó ejemplos sobre programas de auditoría y auditorías útiles a realizar.

Safa Karandish, FDA Consumer Safety Officer, gave clarification regarding the requirements for determining donor eligibility. She briefly reviewed the requirements and gave examples to accompany them.

This webinar was held live on September 21, 2016, at 11:00 ET. Marcelo Fernández-Viña, PhD, HLA Consultant in the HLA Laboratory at Stanford Medicine Blood and Marrow Transplant Program, gave an overview of histocompatibility testing in HCT and the impact on clinical outcomes driving test selections.

This webinar was live on February 8, 2017, at 11:00 AM ET. This virtual roundtable consisted of three accredited organizations including the Cleveland Cord Blood Center, the Blood and Marrow Transplant Group of Georgia at Northside Hospital, and the Sarah Cannon Blood Cancer Network. Presenters described how they analyze outcomes, what issues they found, and what they did to improve.

This presentation was live on Wednesday, June 17, 2020. Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, presented Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier highlighted opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan and transplant program.

This presentation was live on Wednesday, April 22, 2020, at 11:00 am ET, 15:00 GMT. Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, presented Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow reviewed the IEC Standards related to labeling and chain of identity and custody and explained FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she described how ISBT 128 coding and labeling can be used with commercial cellular therapy products.

The Eighth Edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards was published on May 17, 2021 and will be effective on August 16, 2021. To support FACT accredited and applied programs during this transition, FACT is offering a webinar on how to navigate the Eighth Edition Cellular Therapy Standards. Dr. Paul Eldridge from Levine Cancer Institute, the Standards Committee Chair, will explain changes including: • Genetically-modified cellular therapy products • Training in GXP • Quality management • Informed consent • Labeling • Storage

This webinar presents information regarding umbilical cord blood unit selection for stem cell transplantation in adults, including HLA match, unit size, one versus two units, and other important variables.

Robyn Rodwell, PhD of the Queensland Cord Blood Bank at the Mater and Dennis Gastineau, MD of the Mayo Clinic provide practical information regarding the responsibilities of the bank, the transplant center’s processing facility, and the clinical unit.

The University of Kentucky Markey Cancer Center provides tips on how to prepare a program for a FACT inspection.

Federico Rodríguez Quesada BSMT, SBB (ASCP), del Centro Médico Banner Estrella, explicará el propósito, los elementos necesarios y el mantenimiento del POE de POEs

For Inspectors only - This webinar provided practical tips and suggestions to inspectors on how to professionally handle uncomfortable situations during inspections, including, but not limited to, inconclusive demonstrations of compliance, disagreements between the applicant and the inspector, and unprepared programs.

This webinar was live on Wednesday, October 14 , 2020. Process Validation is the second webinar in the new Quality Management Series, Module 10: Validations. Jacklyn Stentz MT (ASCP), Quality Program Manager at Baylor University Medical Center, and Deborah Griffin, MS, ASQ CPGP, consultant at FACT Consulting, discussed the following: • Range to validate (where to start and when to stop), variables and extreme scenarios • Process validations (to include Bone Marrow process) • Verification: when is it needed

This webinar was presented live on Wednesday, August 19, 2020. Validation Overview is the first webinar in the Quality Management Series, Module 10: Validations. Nicole Prokopishyn, PhD, Cellular Therapy Lab Director at Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children's Hospital, Tom Baker Cancer Centre, and Calgary Laboratory Services, discussed the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

This webinar was held on January 10, 2018, at 11:00 am ET. Mary Ann Kelley, DFCI, Associate Director of Quality Assurance CMCF at Dana Farber Cancer Institute / Cell Manipulation Core Facility, discussed how staff is critical in the document control process, including developing, revising, reviewing, training, and accessing records. It included information about protocols, and how to give staff access if programs rely on protocols instead of programmatic SOPs. This is the second webinar in the QM Series, Module 8.

The is the last webinar in the QM Series 8, Document Control. The entire document control process and system must be in place for all critical documents including labels, worksheets, and policies and procedures. Nicole Prokopishyn, PhD, Cellular Therapy Lab Director at Alberta Blood and Marrow Transplant Program, explained the document control process of labels; Cynthia Morris, MSN, RN, CPHQ, Transplant Quality Program Manager at St. Jude Children's Research Hospital, discussed the document control process of worksheets; and Natalia Lapteva, PhD at the Houston Methodist Hospital Bone Marrow Transplant Program, reviewed the document control process of policies and procedures.

This webinar was live on Wednesday, February 5, 2020, at 3:00 pm ET, 20:00 GMT. 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, gave an overview of their program’s audit process and how they write audit reports.

This webinar was live on March 6, 2019. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, discusses 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.

This webinar is the first event for the Quality Management Series Module 6: The Quality Organization. Therese Dodd, RN, MBA, CPHQ, Quality Improvement Director at Sarah Cannon Blood and Marrow Transplant Program, shared her experience and success with organizational structure and charts.

Join FACT-JACIE and the WBMT for a webinar, Quality and Accreditation for Cellular Therapy: A Global Perspective. Presenters described the essential requirements for establishing a hematopoietic stem cell program and emphasized the required quality elements. Existing tools to help achieve accreditation in low and middle income countries were discussed, and presenters shared their experience in developing a Cellular Therapy quality program in the Asia-Pacific region. Presenters include: •WBMT representative: Dr. Dietger Niederwieser, Professor of Medicine and Head of Hematology and Oncology at University Hospital Leipzig, Germany •APBMT representative: Dr. Alok Srivastava, Centre for Stem Cell Research at Christian Medical College Vellore, India •FACT/JACIE representative: Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program. Webinar Moderators: •Dr. Joseph Schwartz, Transfusion Medicine and Cellular Therapy •Eoin McGrath, Director, Advocacy and Quality of Care Department at EBMT.

A corrective action plan (CAP) is an important quality management tool for any program. A CAP is a method of documenting non-compliance issues, identifying their root causes, and capturing measurable, achievable solutions and realistic deadlines. John McCarty, MD from the VCU Health Cellular Immunotherapies and Transplant Program, Elizabeth Ferraro from FACT and Nebraska Medicine, and Phillip Johnson MMedSc(Path) from the Queensland Cord Blood Bank at the Mater discussed developing, implementing, monitoring, and assessing a CAP from their program’s perspective on November 9, 2022.

This webinar was live on February 10, 2016, at 11:00 EDT. The presenters gave an overview of how their organizations set up a Quality Management program and maintained a culture of quality in the organization. This webinar was the last session in the Quality Management Series Module 6: The Quality Organization.

This webinar explains the FACT requirements for reporting quality management activities to program and bank personnel.

This presentation was live on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, described significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provided examples for effective implementation.

This NetCord webinar was presented live on July 13, 2016, at 11:00 EDT. Mike Halpenny MLT (CMLTO), Manager of Stem Cell Manufacturing for Canadian Blood Services, explained volume reduction, applying HES and Non-HES, including quality controls, as they refer specifically to the processing procedure.

In this webinar you’ll hear from several of the association’s leaders about progress to date and plans for the months ahead addressing industry priorities of advocacy, market expansion, quality assurance, public and healthcare provider education, and research and development.

Nicole Watts, PharmD, BCOP, Clinical Pharmacy Specialist at the University of Alabama at Birmingham, discusses the role of pharmacists in the management of immune effector cellular therapy and provides updates to the FACT pharmacy requirements. Dr. Watts also provided education regarding toxicity identification and management, including CRS and CRES, the role of Tocilizumab, and the role of steroids.

This webinar discusses the role the QM Supervisor fulfills in a cellular therapy program or cord blood bank.

This presentation was live on Friday, March 13, 2020, at 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, presented on the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley discussed the growth and expected direction of IEC Accreditation and described the major concepts addressed in the FACT IEC Standards. He also explained various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.

This virtual roundtable consists of short presentations from three cellular therapy programs of varying services, sizes, and locations regarding the time, effort, and resources they utilized to achieve FACT accreditation.

For Inspectors only - This tutorial explains the expectations of both mentors and inspector trainees during the training inspection.

This webinar was presented live on June 22, 2016, at 11:00 ET. Stephen Spellman, MBS, is the Director of the CIBMTR Immunobiology and Observational Research Programs and serves as a Scientific Director for the Immunobiology and Graft Versus Host Disease Working Committees of the CIBMTR. Mr. Spellman gave an overview of how CIBMTR data is used to determine outcomes, and how Clinical Programs can use additional data to further evaluate outcomes and improve.

In anticipation of World Cord Blood Day, FACT, Hema Quebec, and Liege Cord Blood Bank hosted a special Cord Blood webinar on Thursday, November 14, 2019 at 10:00 am ET, 15:00 GMT, and 16:00 CET. The purpose of this webinar is to better understand immunogenetic diversity in registries and cord blood banks, as well as cord blood transplantation and emerging pathogens. This was presented in French. . Topics include: • Immunogenetic Diversity in Registries and Cord Blood Banks: Dr. Eliane Gluckman • Cord Blood Transplantation and Emerging Pathogens: Is there reason for concern? Dr. Gilles Delage • Personal experience of Mathias Malzieu, recipient of a cord blood transplantation, singer of the Dyonisos group, and writer of "Journal d'un Vampire en Pyjama"

This WMDA-NetCord webinar was March 21, 2018, at 11:00 ET. Cellular therapy departments must thaw cord blood units, and they often use very different processes from the procedures outlined by the cord blood bank providing the unit. These SOPs are sent by the cord blood bank and are not always adapted to the disposals and reagents used by the department who then thaw the units. Diane Fournier, PhD, of Héma-Québec, and Roger Horton, PhD, of The Anthony Nolan Cord Blood Bank, discussed manual and automatic thawing methods used by different departments for thawing of these units, and what can be done to improve recovery of the cells. Also, a multi-center study for harmonization of post thaw analysis of CD34 and CD45 cells was presented.