EDUCATIONAL RECORDINGS (141)

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This training video is required for all active inspectors performing virtual inspections.

Inspector - $0.00
Product #700

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.

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Product #336

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #123580

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #123585

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #123584

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #123587

Presenters describe how the FACT Common Standards can help advance cellular therapy in a variety of ways, including promoting patient safety, protecting the research environment, minimizing liabilities, and increasing support from funding organizations.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #349

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #383

This webinar was held on October 28, 2015, at 11:00 EDT. Katie Boyd, PharmD, from Samford University; Tippu Khan, PharmD, from University of North Carolina Hospitals and chair of the ASBMT Pharmacy Special Interest Group; and Connie Sizemore, PharmD, Lead Clinical Pharmacy Specialist at Blood and Marrow Transplant Group of Georgia at Northside Hospital explained the rationale for adding pharmacy requirements to the FACT-JACIE Standards and provided examples for how to comply with them.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #382

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.

Accredited Organization, Guest, NonMember - $0.00
Inspector, Inspector Trainee - $0.00
Product #393

This webinar was held live on December 8, 2015, at 3:00 PM EST. Dr. Ngaire Elwood of the BMDI Cord Blood Bank, took a look at how criteria should be established, what the literature says, and what governmental agencies require.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #386

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #387

This webinar was held live on November 11, 2015, at 11:00 EST. Dr. Joanne Kurtzberg, Professor of Pediatrics, Program Director, at Duke University Medical Center Blood and Marrow Transplant Program, described different methods for assessing cord blood potency and their advantages and disadvantages. 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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #384

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #392

This webinar was held on March 8, 2016, at 3:00 pm EST. Dr. Robyn Rodwell, Scientific Director at the Queensland Cord Blood Bank at the Mater, gave an overview of quality risk management from the cord blood banking perspective

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #391

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.

Accredited Organization, Guest, NonMember - $100.00
Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #379

This webinar was held on January 13, 2016, at 11:00 EST. Dr. Robert Rifkin, Member, Cellular Therapeutics Department, gave an overview of Quality Management principles and elements. This webinar is the third session in the Quality Management Series Module 6: The Quality Organization.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #388

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
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Product #378

This webinar explained the FACT requirements for the annual QM performance report and discussed the intent of the report and ways to report the information.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #329

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #431

Mark Litzow, MD of Mayo Clinic Rochester; Mark Juckett, MD of the University of Wisconsin; and Deborah Yolin Raley, PA-C of Dana Farber Cancer Institute described resources ASBMT and NMDP provide to maintain certifications and competency, including, but not limited to: - Practice Improvement Modules - Training Guidelines for Transplant Physicians and NPs/PAs - BMT Elective Curriculum Rotation

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #347

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #411

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #416

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #435

This webinar recording is a training session for FACT Peer Advisors participating in the ASK-A-PEER program. The session is available to individuals identified as Peer Advisors and members of the FACT Program Relations Committee.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #630

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

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #324

This presentation was live on Wednesday, August 26, 2020. Presenters explained the rationale for FACT accreditation of immune effector cell programs, and compared and contrasted immune effector cell therapy with other non-cell-based therapies. Presenters also summarized the major concepts addressed in the FACT IEC Standards and how to plan a self-assessment against the FACT IEC Standards. Presenters include: Elizabeth Shpall, MD Cord Blood Bank Medical Director, Cellular Therapy Processing Facility Director and Medical Director The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Kris Michael Mahadeo MD, MPH Associate Professor/Section Chief Pediatric SCT-CT The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Alison Gulbis, PharmD The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #12346

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #425

This webinar was on October 26, at 4:00 PM ET. Robyn Rodwell, PhD, of Queensland Cord Blood Bank at the Mater, talked about quality management for cord blood banks.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #404

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #405

This presentation discusses Cellular Therapy Clinical Program inspections.

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #119

This presentation discusses Cellular Therapy Collection Facility inspections

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #120

This tutorial reviews the FACT cellular therapy requirements for evaluating donor suitability and eligibility, provides examples of donor screening questions, and discusses common issues encountered during donor evaluation.

Accredited Organization, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #126

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #450

Ed Brindle and Michele Sugrue discuss maintaining sanitary conditions, documenting cleaning and maintenance, as well as common citations associated with related FACT Standards.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #359

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

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #117

Sheryl McDiarmid, RN, BSN of Ottawa General Hospital and Olive Sturtevant, MHP, MT(ASCP), SBB/SLS explained the FACT requirements for competency assessment and provided practical examples.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #344

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #414

This webinar discussed the need to assess facility parameters and environmental conditions for risk to cellular therapy product integrity and how to demonstrate ongoing compliance with the related FACT Standards.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #363

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

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #325

Dr. Catherine Bollard and Dr. Joanne Kurtzberg give a summary of current practices related to cord blood testing and preparation for administration and reports of adverse events, such as shocked heart syndrome. Included is a review of the relevant FACT Standards as well as common citations.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #371

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #441

Anytime that the temperature is above -150° C should be considered a potential warming event. Because unit volumes are small and are frozen in bags with large surface areas, their thermal kinetics are greatly affected by their environment. In this webinar, Phillip Johnson MMedSc(Path), BAppSc(MedSc), Production Manager at Queensland Cord Blood Bank at the Mater, discusses methods used to define, assess, and document cord blood warming events.

Accredited Organization, Guest, NonMember - $500.00
Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #442

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #436

María José Jiménez Lorenzo of Hospital Germans Trias i Pujol-Institut Català d'Oncologia (ICO) Badalona Servicio de Hematología, Barcelona, proporcionó consejos sobre cómo establecer, implementar, mantener y mejorar continuamente el plan de gestión de calidad.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #418

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.

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #305

This Virtual Roundtable discusses the challenges and successes of performing quality assessments in cellular therapy programs and a cord blood bank.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #304

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #448

On January 30, 2019 FACT presented 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 discussed FACT requirements for exceptional release, and then shared their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #444

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #352

Ed Brindle, of Insception Lifebank Cord Blood Program, Insception Biosciences, and Dr. Elisabeth Semple, of Cells for Life Cord Blood Institute, Inc., explain how FACT accreditation benefits private cord blood banks. They also explain how the NetCord-FACT Cord Blood Standards apply to the private cord blood banking industry.

Accredited Organization, Guest, NonMember - $0.00
Inspector, Inspector Trainee - $0.00
Product #353

Accredited Organization, Guest, NonMember - $100.00
Inspector/Inspector Trainee - $0.00
Product #123579

This webinar provides a broad introduction to TILs and a review of current clinical experience and unique considerations in TIL manufacturing.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #123578

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

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #471

A corrective action plan (CAP) provides a well-documented means of problem-solving and long-lasting change, which in turn can form a disciplined, practical implementation of the actions. Therefore, it is important to ensure that the required tasks in the CAP are implemented and assessed. This webinar promotes continuous improvement by offering important information on implementing, monitoring, and assessing the effectiveness of a corrective action plan. Presenters include Folashade Otegbeye, MBChB, MPH from Fred Hutchinson Cancer Center and Kerri Hill, BSN, from UAMS Cancer Institute.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #474

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.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #475

Michele Sugrue, MS, MT(ASCP)SBB of Shands Hospital at the University of Florida and Leslie Lehmann, MD of Dana-Farber Children's Hospital Cancer Care Pediatric Stem Cell Transplantation Program explain the FACT requirements for continuing education. The presenters provide ideas for regularly educating personnel in both cellular therapy programs and cord blood banks. Note: This webinar is also included in the QM Series: Module 4 at a discounted rate.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #346

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #407

El webinar de este mes fie presentado por Carlos Ramos, MD de Baylor College of Medicine en Houston, Texas. Dr. Ramos revisado el proceso de control de documentos y explicado por qué el sistema de control de documentos es importante e indispensable en el manejo apropiado de documentos críticos: (por ejemplo, procedimientos, normativas, formularios, hojas de trabajo, etiquetas). Este webinar analizado cómo el sistema de control de documentos gestiona el desarrollo, aprobación, implementación, distribución, revisión, revisión, mantenimiento, uso, almacenamiento, seguridad, archivo y eliminación de documentos.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #433

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #429

Three organizations share their experiences preparing for FDA cord blood licensure and/or the IND process.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #334

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #368

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #422

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #399

This webinar was live on November 16, 2016, at 11:00 am ET. Cellular therapy, and healthcare in general, are at the forefront of several initiatives to increase quality in patient care. The blood and marrow transplant field has been a leader in voluntarily improving quality, and new FACT accreditation requirements have been implemented to facilitate real results that have a direct impact on patients.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #402

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #412

Dennis Gastineau, MD, of the Mayo Clinic in Rochester and Ed Brindle, of Insception Lifebank Cord Blood Program describe requirements for initial and ongoing training and discuss ways to prioritize training programs based upon relative risks.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #343

Inspector, Inspector Trainee - $0.00
Product #426

This webinar highlighted the importance of and techniques for participating in an inspection exit interview.

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #132

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.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #456

Full implementation of ISBT 128 labeling and coding is required by the seventh edition of the FACT-JACIE Hematopoietic Cellular Therapy Standards, effective May 30, 2018. On Thursday, June 14, 2018, Dr. Phyllis I. Warkentin discussed common questions about ISBT 128 terminology, product codes, FACT Standards, and regulatory requirements in this 90 minute webinar.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #438

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.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #455

This webinar was presented on January 25, 2017, at 11:00 AM ET. Dr. George Selby, BMT Program Medical Director at OU Medical Center Blood and Marrow Transplant Program, described how to effectively design outcome analyses that provide actionable data. By selecting appropriate variables and collecting adequate information, root cause analyses will not only show what outcomes were, but also offer clues regarding who in your patient population have undesirable trends and why. Asking these questions at the outset of the analysis will make root cause analysis and corrective actions more manageable. This was the 3rd webinar in the QM Series, Module 7: Outcome Analysis.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #410

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

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #465

This webinar discusses a prospective study on behalf of Eurocord and NetCord on Cord Blood CD34.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #340

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #345

This webinar, presented by Paolo Rebulla, MD, discusses basic concepts in cryobiology related to ice formation in biological materials during transition from liquid to frozen phase.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #342

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #350

Joanne Kurtzberg, MD of the Carolinas Cord Blood Bank. describes special considerations for cord blood transplant recipients to promote good clinical outcomes and reduce risks of adverse events.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #351

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #341

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #408

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #413

Únase a nosotros para el primer webinar el 20 de octubre de 2016, a las 9:00 CT (México), 14:00 GMT, 16:00 CET (España). El Dr. Carlos Bachier, Presidente del FACT-JACIE Comité Internacional y Raquel Espada, Coordinadora de Acreditación JACIE, presentarán una visión general del Programa de Acreditación conjunto FACT-JACIE Internacional basado en un enfoque gradual para lograr el cumplimiento con los estándares FACT-JACIE para la Recolección, Procesamiento y Administración de Productos Hematopoyéticos de Terapia Celular.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #401

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

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #125

This webinar explains what outcome analysis is and why it is important to cellular therapy programs and cord blood banks.

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #300

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #421

Transplant centers and cord blood banks are at risk of many kinds of man-made and natural disasters — fire, bomb threat, power outage, viral epidemic, flood, tornado, hurricane, earthquake. Some emergencies arrive with brief advance warning. Others with no warning at all. The harm to patients and threat to the facility can be mitigated by thinking ahead about the unthinkable and having a plan. In this webinar, Alan Leahigh gives step-by-step guidance on preparing for, responding to, and recovering from an emergency.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #357

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

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #415

Accreditation Coordinators for preparing for an on-site FACT inspection.

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #115

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.

Inspector, Inspector Trainee - $0.00
Product #301

This Quality Management Series 10 Webinar: Program Perspective of the Validation Process was live on December 7, 2021. Dr. Joseph Schwartz, MD, MPH, from Mount Sinai Bone Marrow and Stem Cell Transplantation Program discussed the clinical approach to process validation and software validation. Jeannette Bloom MBA, MT(ASCP)SBB, discussed the apheresis and processing approach to validation and software validation from Baylor College of Medicine Stem Cell Transplant program's perspective, and Walid A. Almashaqbeh BS, BB (ASCP), discussed the cord blood banking approach to validation and software validation from King Abdulaziz Medical City's program perspective.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #467

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

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #459

This webinar was presented live on December 2, 2020. Software Validation is the third webinar in the Quality Management Series, Module 10: Validations. Robyn Rodwell, PhD, MSc (GMP & QM), previous director of the Queensland Cord Blood Bank at the Mater, and Guy Klamer, PhD, from the Sydney Cord Blood Bank, discussed the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include: • Critical electronic systems under the control of the organization (facility) • Spreadsheets • Vendor and organization responsibilities

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #462

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #458

This FACT QM 11 Webinar: Overview of Corrective Action Plans was presented live on February 16, 2022. Dr. Carlos Bachier from Sarah Cannon Transplant and Cellular Therapy Program at Methodist Hospital in San Antonio, and Lisa Cantwell MHA, CPHQ from the Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa, discussed the following: 1. When a corrective action plan is needed 2. The purpose of a corrective action plan 3. Who should be involved 4. Short term Immediate corrective action, and long-term preventive correction action 5. How to assess the effectiveness of a corrective action plan

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #470

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #123590

This webinar was presented live on November 30, 2016, at 11:00 ET. Dr. Dennis Gastineau reviewed the requirements for meeting or exceeding expected one-year survival of HPC transplant recipients. The presentation shared information such as requirements for corrective action plans, actions that improved one-year survival for programs, and benchmarks for autologous and non-U.S. programs. This is the first webinar in the Quality Management Series, Module 7.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #406

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #430

This presentation was held on Wednesday, January 24, 2018, at 11:00 am ET. Rebecca Maddox, Compliance Coordinator at Mayo Clinic Florida, discussed the following:  The advantages and disadvantages of using a system  How to incorporate an electronic system into your program  Considerations to take into account when evaluating systems  How to assess a system for compliance with the FACT Standards  What works well with her electronic system and what surprises she encountered

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #432

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #439

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #420

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.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #453

This webinar was live on June 11, 2019. Dr. Gordana Svajger, Quality Compliance Program Manager for the BMT/CT Program at The Hospital for Sick Children in Toronto, CANADA, discusses performing follow-up to assess the effectiveness of the actions implemented on correcting the errors. This is the third webinar in the QM Series 9: Audits.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #447

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #446

This webinar was presented live on January 23, 2019. Leigh Poston, BMT Program Quality Management Coordinator, discussed designing audit strategies, identifying specific audits to perform, creating an audit schedule, determining the scope of the audit, and executing the audit. This is the first webinar in the QM Series 9: Audits.

On-Demand Download - $100.00
Industry - $500.00
Inspector and Inspector Trainee - $0.00
Product #443

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.

Accredited Organization, Guest, NonMember - $100.00
Accredited Organization, Guest, NonMember - $20.00
Inspector, Inspector Trainee - $0.00
Product #375

This webinar discusses in detail the importance of qualification and validation studies in a Quality Management Program.

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #330

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #466

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

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #118

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.

Non-industry registrants - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #476

This virtual roundtable is the capstone event for the Quality Management Series Module 5: Facilities. Three FACT-accredited programs, including both transplant centers and a cord blood bank, discussed their approaches toward designing, cleaning, and monitoring their work environments.

Accredited Organization, Guest, NonMember - $100.00
Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #374

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #390

This webinar explains the requirements for reporting QM changes, deviations to policies and procedures, and cellular therapy product deviations.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #333

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

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #328

During this virtual roundtable, a panel of cellular therapy programs and cord blood banks discuss the use of mock inspections as a self-assessment tool for preparation for FACT inspections.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #332

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #451

This webinar was live on August 10, 2016, at 11:00 EDT. Dr. Lawrence Lamb, from The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program, gave an overview of specialty operations and clean rooms as they pertain to the FACT-JACIE 6th Edition Cellular Therapy Standards.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #398

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #396

This webinar was presented live on July 27, 2016, at 11:00 EDT. Dr. Chris Carey, from Hoxworth Blood Center University of Cincinnati Academic Health Center, gave an overview of and rationale for requirements for temperature and humidity control in collection facilities.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #397

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.

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #377

This presentation was live on Monday, June 22, 2020. Presenters discussed how cord blood banks have been managing through the COVID-19 pandemic: Heidi Elmoazzen, PhD Canadian Blood Services' Cord Blood Bank & Stem Cell Manufacturing Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank. Roger Horton, PhD Anthony Nolan Cord Blood Bank, United Kingdom Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will give detail on collections, processing, storage, distribution, product protection, and staffing to show how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners. Arvin Faundo MD Cordlife Group Limited, Singapore Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks. Donna Regan MT(ASCP), SBB NMDP Director Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning. WMDA

Everyone - $0.00
Product #457

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #440

This webinar was held live on October 12, 2016, at 11:00 AM ET. Medhat Askar, MD, PhD, MSHPE, FRCPath, Director, Transplant Immunology at Baylor University Medical Center, gave an overview of the nuts and bolts of tests implementation and ASHI laboratory accreditation.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #400

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

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #331

This tutorial explains the purpose, required elements, and maintenance of the SOP for SOPs.

Accredited, Guest, NonMember - $50.00
Inspector, Inspector Trainee - $0.00
Product #113

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.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #454

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #419

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.

Accredited, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #303

Dr. Marta Torrabadella-Reynoso, MD discusses training and documentation recommendations. Dr. Torrabadella-Reynoso also includes example policies, methodologies, and SOPs for cord blood collectors.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #355

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

Inspector, Inspector Trainee - $0.00
Product #103

This virtual roundtable provides examples of how to transition to new editions of FACT Standards, including both the Cellular Therapy Standards and Cord Blood Standards.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #327

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #424

This webinar was on June 26, 2019 at 11:00 am ET. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, graciously shared their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements. Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters provided step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT inspection team.

Accredited Organization, Guest, NonMember - $100.00
Industry - $500.00
Inspector, Inspector Trainee - $0.00
Product #449

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #394

This FACT Webinar titled, Validation and Qualification Principles and Protocols for Cellular Therapies, was live on Wednesday, February 6, 2019. Dr. Tom Leemhuis, Laboratory Director, and Angela Damen, MS, Clinical Laboratory Scientist II, at Hoxworth Blood Center University of Cincinnati Academic Health Center, discuss the Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #445

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"

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #452

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #427

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #423

This presentation was held on Wednesday, February 7, at 10:00 am CT, 11:00 am ET, 4:00 pm GMT. Linda Moss, RM, of Anthony Nolan Cell Therapy Centre, thoroughly reviewed the different methods banks use to obtain informed consent, and the pros and cons of each method.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #434

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.

Accredited Organization, Guest, NonMember - $100.00
Inspector, Inspector Trainee - $0.00
Product #437

In anticipation of World Cord Blood Day, FACT, along with Hema Quebec and Liege Cord Blood Banks, hosted a special Cord Blood webinar on Monday, November 16, 2020 to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is complimentary, and was presented in French. Presenters include: •Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada) •Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole "collection and transplantation of HSC" at the Agence de Biomédecine. (France)

Accredited Organization, Guest, Inspector, Inspector Trainee, NonMember - $0.00
Product #12347

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