Products (181)

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 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.

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

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

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 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 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.

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 module of the QM Series consists of sessions related to corrective action plans associated with cellular therapy programs and cord blood banks.

This module of the QM Series consists of sessions related to reporting quality management information. Detailed information regarding routine reporting, the annual QM performance report, and reporting QM changes and deviations is provided.

This module of the QM Series consists of sessions related to quality management of facilities. Detailed information regarding facility design, facility cleaning, and control of facility parameters is provided.

This module of the QM Series consists of sessions related to outcome analysis, specifically related to cellular therapy programs and cord blood banks.

This module of the QM Series consists of sessions related to the auditing process associated to cellular therapy programs and cord blood banks.

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

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.

The major objective of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and related therapies using hematopoietic-derived cellular products.

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.

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.

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

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.

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

The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.

The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.

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

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.

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.

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.

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 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.

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)