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FACT assists its constituents with identifying educational sessions that are applicable to their organization. FACT’s Allied Learning Center is a collaborative effort between FACT and AABB, ASBMT, ASFA, ASHI, CAP, ISCT, NETCORD, NMDP, PACT, and others to provide a centralized resource for organizations to quickly and easily obtain online modules applicable to their operations and/or training needs. FACT encourages accredited organizations to utilize these educational activities to maintain knowledge of industry practices and regulations. The sessions listed in the Allied Learning Center are in addition to the FACT educational program, including live events and educational recordings.

Online educational sessions offered by our partners are listed in topical order:
Quality Management
Clinical Programs
Collection Facilities
Processing Facilities
Cord Blood Banks
Regulations
Notable Sessions

These educational offerings are solely for programs’ educational use and do not represent FACT and are not intended to be complete or accurate informational sources for complying with FACT requirements. Each program, facility, and individual should analyze its practices and procedures to determine if it meets the standard of practice in the community or governmental laws or regulations. FACT disclaims any responsibility for the information presented in these educational offerings and expressly does not represent or warrant that the information presented meets FACT requirements, standard of practice, or governmental laws or regulations.

QUALITY MANAGEMENT

Root Cause Analysis  (AABB) 
Description: This webinar recording examines root cause analysis techniques used to find errors and events critical to problem solving--- identifying root causes or faults and problems that cause operating events. Speakers explore techniques and apply common tools for corrective or preventative actions using real cell processing events and examples. 

Adverse Events and Reactions In Cellular Therapy (PACT)  
Description: This free webinar recording discusses adverse events associated with cell therapy products, adverse event reporting, and safety reporting in cell therapy clinical trials. 

Quality Control of Manipulated and Cryopreserved Grafts (ISCT) 
Description: This webinar provides information on validation requirements and procedures for quality control methods as well as on quality control data of manipulated (selection, depletion) and/or frozen grafts. In order to improve release criteria for new cellular therapy products (e.g. Biologics or ATMP) multi-colour flow cytometry analyses is provided. 

Vendor Qualifications (ISCT)
Description: This webinar describes how to conduct vendor qualification either on-site or off-site, and shows how a scoring system can directly correlate supplies/reagents to what type of vendor qualification is required.  

CLINICAL PROGRAMS  

International Hematology Club Meeting: A Focus on Lymphoid Diseases (IHC, November 6-7, 2015 in Paris, France) 
Description: This meeting will share up-to-date information and provide a unique opportunity for world class leaders in the field to discuss vital and contentious issues in hematology. This thought-provoking dialogue will address the most challenging current academic clinical and technological questions and will provide clinicians with state-of-the-art recommendations regarding patient care. Cutting-edge data related to disease pathophysiology, rare entities, multiple myeloma, chronic lymphocytic leukemia and lymphoma therapy will be included.

BMT Training Programs (ASBMT) 
Description: ASBMT compiles information on programs offering a blood and marrow fellowship (BMT) or hematology/oncology fellowship with strong BMT emphasis. This listing also includes programs offering clinical electives for students, residents, and fellows.

Chronic Graft Versus Host Disease Practice Improvement Module (ASBMT)
Description: The Chronic Graft versus Host Disease module is based on the NIH Consensus Development Project (Filipovich et al. Biology of Blood and Marrow Transplantation 2005; 11:945-955) and includes five measures for the management of disease. Available only to ASBMT members, and is free of charge.

Infection Control Practice Improvement Module (ASBMT) 
Description: Six measures are included in the Infection Control module that is based on the Guidelines for Preventing Infectious Complications (Tomblyn et al. Biology of Blood Marrow Transplant 2006; 15:1143-1238). Available only to ASBMT members, and is free of charge.

Caring for HCT survivors: A review of the 2012 Guidelines to monitor late effects (NMDP/Be The Match)
Description: Join Dr. Navneet Majhail as he reviews key updates from the 2012 publication, Recommended screening and preventive practices for long-term survivors after HCT1. This 45-minute webinar will help you understand the updated guidelines for long term follow-up care of HCT survivors, provide ideas for implementing these guidelines into your practice, and review free resources to help you share these recommendations.

Pediatric Survivors After HCT (NMDP/Be The Match) 
Description: Following hematopoietic cell transplantation (HCT), pediatric recipients face a high incidence of  late effects, underscoring the need for long-term monitoring and early detection. To optimize the long-term care for patients with malignant and non-malignant diseases, this case-based activity explores post-autologous and allogeneic HCT screening recommendations, including: risk factors associated with exposures and late effects, screening and assessment guidelines, and vaccination schedules. 

AML and MDS in older adults (NMDP/Be The Match) 
Description: Explore practical applications of classification and research data to compare treatment choices for older AML and MDS patients, including: How diagnostic testing has changed the timing of therapeutic choices and if age should be considered; Applying data to mitigate risk and optimize the benefit among new drugs, transplantation, and combination approaches; What coverage options are available for Medicare-eligible patients.

A Case-Based Approach to CLL and Mantle Cell Lymphoma (NMDP/Be The Match)
Description: Using a case-based format and the latest research, experts address the clinical management of patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) and discuss both frontline and salvage therapies. Such therapies will include conventional chemotherapy, novel agents as well as transplant approaches. For CLL, what is the risk-adapted sequence for treatment and who can benefit from earlier and more aggressive therapeutic interventions, including hematopoietic cell transplantation (HCT)? For MCL, what are the optimal therapeutic approaches for this challenging disease using standard agents, novel approaches, and HCT?

BMT CTN State of the Science Symposium 2014 Report (NMDP/Be The Match)
Description: The NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) has enrolled more than 6,000 patients in 31 trials since 2001. The third State of the Science Symposium was recently held to bring together 12 committees of leaders in HCT to address critical issues and present their proposals for future study. Following the symposium, leaders in the field then selected the highest priority projects for the next seven years. View the presentations to learn about the findings and understand the roadmap for future BMT CTN trials in the U.S. 

Four-Part CME Series: Management of Advanced Non-Hodgkin Lymphomas (NMDP/Be The Match) 
Description: This series provides an overview of four different disease subtypes of non-Hodgkin lymphoma where transplantation is an option for treatment. The lectures discuss choices for first-line and second-line treatment and options for the patient who relapses or is refractory to current treatment. 

Modified T cells: The implications of their use in the arenas of HIV and Cancer (ISCT, March 2011) 
Description: Gene-modified T cells were the first gene therapy tool used in clinical gene transfer trials. After the first applications in immunodeficiency diseases, T cell gene therapy has been extended to HIV infection and cancer. In this webinar, two experts provide their insights in this cutting edge field. 

Graft vs Host Disease (ASFA) 
Description: This webinar recollects the types of hematopoietic cell transplantation, lists common signs and symptoms of acute and chronic graft-versus-host disease (GVHD), and understand how GVHD happens and what is done to treat it. 

Results of the BMT CTN Protocol (0201) PBSC versus Marrow Study (NMDP/Be The Match)  
Description: Results of the BMT CTN Protocol 0201 PBSC versus Marrow study were presented during the Plenary session at the 2011 American Society of Hematology (ASH) Annual Meeting in San Diego. This webinar recounts this presentation on the randomized, multicenter, phase III trial that compared survival rates for patients receiving PBSC with patients receiving bone marrow. 

Decision to Pursue HCT for Sickle Cell Disease (NMDP/Be The Match) 
Description: This program provides information on the benefits and risks of deciding to pursue transplantation as a treatment option for patients with SCD. You will learn about the advances in allogeneic transplantation for patients with SCD and the importance of shared decision making among this patient population.

COLLECTION FACILITIES

Marrow Collection Procedures Video (NMDP/Be The Match, Available to members of NMDP/Be The Match or CIBMTR Networks)
Description: View examples of current best practices in standard marrow collection methods to help you collect the best possible product while ensuring donor safety.

Dendritic Cell Vaccines for Prostate Cancer (ASFA)
Description: Online registration for the webinar on January 23, 2013 at 12:00 pm ET.

Photopheresis (ASFA)
Description: Online registration for the webinar on October 16, 2013 at 12:00 pm ET.

Pediatric Stem Cell Collection (ASFA) 
Description: This webinar addresses how to recognize the unique aspects of pediatric stem cell collections such as size, lines, and primes; identify diseases for which pediatric stem cell collection may be performed; address product volume collection challenges.

Unexpected Reactions in Donor & Therapeutic Apheresis Procedures (ASFA) 
Description: This webinar reviews common and uncommon adverse events associated with apheresis procedures, discusses mechanisms of select adverse events and potential interference therapeutic drug levels, and considers interventions to minimize undesirable effects during or after apheresis procedures.

What's in the Bag? A Look at the Contents of a Stem Cell Collection Bag (ASFA)
Description: This webinar familiarizes viewers with the lining-up of WBC subsets in a centrifugal field, with hematopoietic stem cell mobilization strategies and stem cell graft requirements, and with accessory cells (T-, B-, NK-cells) and WBC subsets that have a potential use for solid-organ tissue repair.

Pediatric Apheresis (ASFA)
Description: This webinar describes the goals of therapeutic apheresis, defines indications for therapeutic apheresis in pediatric patients, and lists clinical applications of apheresis and rationale for using apheresis in selected diseases.

Mobile Apheresis (ASFA) 
Description: Upon completion of this presentation, the participants should be better able to describe the similarities and differences of a mobile apheresis program versus a single institution apheresis program; articulate the operations, logistic, and financial aspects of planning and setting up a mobile apheresis program; discuss the clinical training, supervision, education and quality programs necessary to operate a high quality mobile apheresis program.

Proficiency Testing for Transfusion Medicine (CAP) 
Description: Several proficiency tests for Transfusion Medicine related to Hematopoietic Progenitor Cells are available through the College of American Pathologists. 
    

PROCESSING FACILITIES

Training/Competency Program for CT Facilities (ISCT) 
Description: A strong training and competency program is an essential component of a cellular therapy laboratory. It ensures that regulatory requirements are met and that safe, effective products are supplied to patients. This webinar reviews potential problem areas in training and provides ideas for how to strengthen your training programs.

Potency Assays for Mesenchymal Tissue Regeneration (ISCT) 
Description: This webinar addresses how it is possible to establish potency assays for adult multipotent mesenchymal progenitors by distinct strategies dissecting both cellular differentiation and soluble factors release. Two distinct paradigms of cell-based regeneration are proposed, on one side bone regeneration and on the other side cardiac repair.

Clean Room Facilities: Cleaning Best Practices (ISCT)
Description: The Lab Practices Committee and ISCT sponsored a work group to survey internationally to determine routine sanitization and cleaning practices currently in use. This webinar discusses these survey results and outlines practices regarding appropriate facility/equipment cleaning and sanitization involved in the manufacture and processing of cellular therapy products.

Volume Reduction Technology for Large Scale Harvest or Post-thaw Manipulation of Cellular Therapeutics (ISCT) 
Description: This webinar discusses two examples of available of new technologies for cell product manipulation that come into play during and after successful scale up, namely at the time of banking and at the time of administration.

CD34 Enumeration, How and When (ISCT)
Description: This webinar discusses the most important parameters and issues that influence final CD34 counts.

Stem Cell Processing Proficiency Testing (CAP) 
Description: Processing Facilities seeking proficiency testing for laboratory assays can enroll in the CAP Stem Cell Processing Survey (Code SCP). Procedures such as Absolute CD34, Bacterial Culture, Colony Forming Units (CFU), and Viability are included among others.

CORD BLOOD BANKS

Cord Blood CD34 and Cell Content (NetCord) 
Description: This webinar will be on Thursday, January 31, 2013 at 1400 GMT. Riccardo Saccardi, MD, of Careggi University Hospital Cord Blood Bank in Florence Italy, will discuss a prospective study on behalf of Eurocord and NetCord on Cord Blood CD34.

Measuring Viability of Cord Blood Products (NetCord) 
Description: This webinar on Thursday, April 25, 2013 at 1300 GMT will be presented by Sergio Querol Giner, MD, PhD of Programa Concordia Banc de Sang i Teixits and Richard Duggleby, PhD of the Anthony Nolan Research Institute. The presenters will will address the various methods for progenitor cell assessment that have been used and their applicability in the CB field.

Cord Blood Cryopreservation (NetCord)
Description: This webinar will be presented on Thursday, July 25, 2013 at 1300 GMT by Paolo Rubella, MD of the Center of Cellular Therapy and Cryobiology at the Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy. The webinar will present basic concepts in cryobiology related to ice formation in biological materials during transition from liquid to frozen phase. Examples will be given of “good” and “bad” cord blood cryopreservation thermal profiles.

Cord Blood Potency and Release (NetCord)
Description: This webinar will be presented on Thursday, October 10, 2013 at 1300 GMT by Gesine Kögler, PhD of the José Carreras Cord Blood Bank. Cord blood units are not only intensively examined during processing before cryopreservation, but also prior to release for transplantation. Therefore, potency of a unit must be defined before release on segments and cryopreserved aliquots. Currently estimation of the potency, i.e., the capability to rebuild the patient’s hematopoietic system, is performed by flow cytometric analysis of CD34+ cells as well as the assessment of CFC formation in a methycellulose-assay. Methodological aspects and technical improvements will be discussed.

Placental Derived Mesenchymal Cells, Isolation, Processing and Characterization (ISCT) 
Description: This webinar focuses on the isolation, processing and characterization of placenta-derived cells, with special emphasis on mesenchymal stromal/stem cells that can be isolated from placental tissues. It also addresses the most significant achievements to date in the field of placental cell-based therapeutic approaches.

Cord Blood Processing Proficiency Testing (CAP)
Description: Cord Blood Banks seeking proficiency testing for laboratory assays can enroll in the CAP Cord Blood Processing Survey (Code CBT). Procedures such as Absolute CD34, Bacterial Culture, Colony Forming Units (CFU), and Viability are included among others. 

REGULATIONS

Regulatory Obligations for Investigator-Sponsored Research (FDA OCTGT)
Description: Pat Holobaugh discusses the regulatory requirements for an investigator who is also a sponsor of an IND or IDE.

Early-Phase Trials of Cellular and Gene Therapies (FDA OCTGT) 
Description: Steve Winitsky discusses the clinical risks of cellular and gene therapy products, and reviews some considerations for the design of early-phase trials of these products.

Pediatric Clinical Trials (FDA OCTGT) 
Description: Steve Winitsky discusses the regulation and design of pediatric clinical trials.

Fast Track (FT) for Products Regulated in OCTGT (FDA OCTGT)
Description: Bindu George discusses Fast Track requests and designation for OCTGT products, including cellular and gene therapies.

IND Safety Reporting (FDA OCTGT) 
Description: Bindu George provides basic information regarding the FDA safety reporting requirements for INDs.

IND Basics in OCTGT (FDA OCTGT)
Description: This presentation looks at the basics of IND submission in OCTGT.

Sponsor Meetings with OCTGT (FDA OCTGT) 
Description: Lori Tull describes various sponsor meetings with OCTGT.

Potency Testing (ISCT)
Description: This webinar reviews US and European regulatory requirements and guidance on potency testing for cell therapy products, including strategies for development and qualification of suitable functional assays.

Preparing for a FDA Inspection (PACT)
Description: This webinar provides an overview of FDA inspections, tips for preparing for an FDA inspection, and inspection/facility notification case studies.

"361" Human Cells, Tissues, & Cellular and Tissue Based Products (FDA OCTGT)
Description: This presentation describes what HCT/Ps are and how they are regulated.

Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products (FDA OCTGT)
Description: This presentation aims to guide manufacturers toward successful development of quality cell and gene therapy products.

Cellular Therapy Products (FDA OCTGT)
Description: This presentation discusses information that is needed to prepare an investigational new drug application for a cellular therapy product.

The Chemistry, Manufacturing and Controls (CMC) Section of a Gene Therapy IND (FDA OCTGT) 
Description: In this presentation, Andrew Byrnes explains the basics of how to put together the CMC section of a gene therapy IND, particularly for Phase 1 trials.

Preclinical Considerations for Products Regulated in OCTGT (FDA OCTGT) 
Description: Allen Wensky provides a basic overview of preclinical considerations that make up one of the three key elements of an IND submission. 

NOTABLE SESSIONS     

Impact of Cord Thaw Method on Processing and Clinical Outcome (ISCT)

Description: These free slides from the 2014 ISCT Annual Meeting compare different cord blood unit thaw methods and how they impact patient safety. 

HLA Education Series (NMDP/Be The Match)
Description: These online education modules discuss several aspects of HLA, including: 1) how HLA matching is used to optimize patient outcomes and examine bidirectional, unidirectional, and graft rejection in transplant; 2) research used to determine the NMDP matching guidelines for unrelated donors and cord blood units; and, 3) HLA naming systems (serology and DNA), allele codes, and the three resolution levels of HLA typing. Account with NMDP/Be The Match learning management system required.

BMT Curriculum (NMDB/Be The Match)
Description: To give you exposure to the exciting biology and clinical practice of blood and marrow transplant, (BMT) leading transplant physicians have come together to develop 16 didactic curriculum modules and several testimonial videos on "why I chose BMT". These modules provide the fascinating history and future of BMT, fundamentals of the science behind transplant, state-of-the-field disease summaries, immunobiology and donor selection, early and late effects and more. One module describes how to mold a career in BMT. These modules can be used for the didactic portion of a BMT elective rotation for medical students and fellows. Other clinicians in hematology/oncology may also find them helpful.

The Transition from Clinical Development of a Cellular Therapy Product to Clinical Manufacturing (AABB)
Description: This webinar recording reviews the process for preclinical development of a novel cellular therapy product from "bench to bedside," focusing on late stage translation to the clinic and regulatory submissions. Experts  describe their  experiences in simplifying, streamlining and standardizing the process, with the ultimate goal of shortening the time to IND submission and approval. 

HLA Typing: An Update for 2013 (AABB) 
Description: This webinar explains the three major uses of HLA testing including solid organ transplantation, hematopoietic stem cell transplantation and disease association/pharmacogenetics testing--- presenting the use of real-time PCR and other molecular methods for HLA typing. The speakers review typing requirements for deceased organ donors and paired kidney transplants, share updated requirements for stem cell transplants as well as discuss the use of “virtual crossmatching” for solid organ transplants and the challenges associated with HLA-DQ antibodies.

Protecting Patients from Harm: Ethical, Legal & Policy Responses to Domestic and International Marketing of Clinically Unproven Stem Cell Interventions (PACT)
Description: This free webinar recording discusses the myth and reality of stem cells and regenerative medicine and the need for protecting patients from harm in the context of recent responses to marketing of unapproved stem cell-based interventions. 

ISBT Implementation: What to do and What not to do (ISCT, 2012) 
Description: This webinar explains where and how to start the implementation process; defines what equipment, materials and software will be needed; describes the set up of an implementation calendar; and describes the keys to success in transition from current labeling system to ISBT 128 compliant labeling system. 

Software for Cellular Therapy Facilities: Homemade versus Commercial and why Facilities chose what they did (ISCT, April 2011)
Description: This webinar discusses what type of software different cellular therapy facilities use and the pros and cons of the software choice.  

The Transition from Clinical Development of a Cellular Therapy Product to Clinical Manufacturing (AABB)
Description: This webinar recording reviews the process for preclinical development of a novel cellular therapy product from "bench to bedside," focusing on late stage translation to the clinic and regulatory submissions. Experts  describe their  experiences in simplifying, streamlining and standardizing the process, with the ultimate goal of shortening the time to IND submission and approval. 

HLA Typing: An Update for 2013 (AABB) 
Description: This webinar explains the three major uses of HLA testing including solid organ transplantation, hematopoietic stem cell transplantation and disease association/pharmacogenetics testing--- presenting the use of real-time PCR and other molecular methods for HLA typing. The speakers review typing requirements for deceased organ donors and paired kidney transplants, share updated requirements for stem cell transplants as well as discuss the use of “virtual crossmatching” for solid organ transplants and the challenges associated with HLA-DQ antibodies.

Protecting Patients from Harm: Ethical, Legal & Policy Responses to Domestic and International Marketing of Clinically Unproven Stem Cell Interventions (PACT)
Description: This free webinar recording discusses the myth and reality of stem cells and regenerative medicine and the need for protecting patients from harm in the context of recent responses to marketing of unapproved stem cell-based interventions. 

HLA Matching Guidelines for Selecting Unrelated Donors and CBUs for HCT (NMDP/Be The Match)
Description: Learn practical applications of the recently updated matching criteria for selection of marrow, PBSC, and cord blood unit (CBU) cell sources. Participants will gain perspective on which pre- and post-transplant factors have the most impact on outcomes, optimal match criteria for selecting marrow, PBSC, and CBUs, and the non-HLA factors that affect cell source decisions. Participants will also learn about ongoing research trials and impact on donor and cord selections and timing.

Case Studies: Applying 2012 HLA Matching Guidelines for HCT Selection (NMDP/Be The Match)
Description: Review patient case studies to apply the latest HLA matching criteria for selection of marrow, PBSC, and cord blood unit (CBU) cell sources for transplant patients with review of the impact on transplant timing and survival.

Software for Cellular Therapy Facilities: Homemade versus Commercial and why Facilities chose what they did (ISCT, April 2011)  
Description: This webinar discusses what type of software different cellular therapy facilities use and the pros and cons of the software choice.

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As a Matter of FACT

FACT was formally known as “FAHCT” (The Foundation for the Accreditation of Hematopoietic Cellular Therapy) until it expanded operations into other cellular therapies beyond hematopoietic cells.

Accreditation Success Story

Hospital Israelita Albert Einstein (HIAE) in Brazil is the first Bone Marrow Transplantation Center in Latin America to receive FACT accreditation. HIAE is accredited for autologous and allogenic transplantation. Read more