QUALITY MANAGEMENT

QM Series 8: Staff Involvement in Document Control: Where do YOU fit in? (FACT), January 10, 2018
Description: This webinar will be 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, will discuss how staff is critical in the document control process, including developing, revising, reviewing, training, and accessing records. It will include information about protocols, and how to give staff access if programs rely on protocols instead of programmatic SOPs.

Facilities for Cord Blood Processing: Gowning-Cleaning Procedures eCast (AABB Center for Cellular Therapies), November 16, 2017-November 16, 2019
Description:Live and On-Demand eCast. This program will demonstrate administrative and engineering practices and policies required to ensure a safely sourced and a sterilely manufactured cellular product (cord blood) produced under aseptic processing conditions with optimum patient safety. This program’s objectives with be accomplished by discussion with these practices.

Quality Plan and FACT (ASFA), November 8, 2017
Description: Join us on Wednesday, November 8, 2017 at 12:00pm - 1:00pm ET for our live webinar presented by Joseph Schwartz, MD, MPH.

QM Series 8: The Document Control Process From Start to Finish (and Back Again!) (FACT), September 13, 2017
Description: This webinar will be on September 13, 2017, at 11:00 ET. Therese Dodd, RN, MBA, CPHQ, of Sarah Cannon Blood Cancer Network, will review the entire document control process and explain why the document control system must be in place for the management of critical documents: (e.g., procedures, policies, forms, worksheets, labels). Also, this webinar will discuss how document control manages the development (preparation), approval, implementation, distribution, review, revision, maintenance, use, storage, security, archival, and disposal of documents. This is the first webinar in the QM Series, Module 8.

Establecimiento e implementación de un plan de gestión de la calidad (FACT-JACIE), July 27, 2017
Description: María José Jiménez Lorenzo del Hospital Germán Trias i Pujol-Institut Català d'Oncologia (ICO) El Servicio de Hematología de Badalona, Barcelona, asesora sobre cómo establecer, implementar, mantener y mejorar continuamente el plan de gestión de la calidad.

Poe de POEs (FACT-JACIE), June 22, 2017
Description: Federico Rodríguez Quesada BSMT, SBB (ASCP), del Centro Médico Banner Estrella, explica el propósito, los elementos necesarios y el mantenimiento del POE de POEs.

Webinar de FACT-Jacie: Funcion del gerente de calidad (FACT-JACIE), April 27, 2017
Description: Dr. Carlos Bachier, Presidente del Comité Internacional FACT-JACIE y Eoin McGrath, Gerente de Operaciones de JACIE, analizan el papel que desempeña el Gerente de Calidad en un programa de terapia celular. La presentación incluyó consejos sobre cómo cumplir con los requisitos de FACT-JACIE, crear una cultura de mejora continua de la calidad y ayudar al personal a implementar elementos de un Plan de GC.

Donor Safety and Selection of Donors On-Demand eCast (AABB Center for Cellular Therapies), June 8, 2017-June 8, 2019

Description: Focus of the program will be on donor safety following the collection of HPC-A and HPC-M products. The speakers will cover an extensive experience of volunteer donors through National Marrow Donor Program and will describe risk factors for the development of complications related to stem cell or marrow donation. Other issues that will be discussed are the need for standardization of the collection process for marrow collection, the need for separation of evaluation and care of related donors and the impact of the size of the collection center on donor toxicities. An algorithm for donor selection based on donor risk and optimal recipient outcome will be presented. The need for standardization of HPC-M collections in order to improve cellular yields and to minimize donor complications will be reviewed.

QM Series: Completing FACT-Required Outcome Analyses (FACT), March 22, 2017
Description: This webinar was 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.

QM Series: Improving Our Clinical Outcomes Virtual Roundtable (FACT), February 8, 2017
Description: This webinar was on February 8, 2017, at 11:00 AM ET. This virtual roundtable consisted of three accredited organizations (including both cellular therapy programs and cord blood banks), who shared how they improved outcomes. Presenters described how they analyzed outcomes, what issues they found, and what they did to improve.

QM Series: Making Outcome Analysis Work for You (FACT), January 25, 2017
Description: This webinar was 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.

QM Series: Benchmarking One-Year Survival  (FACT), November 30, 2016 
Description: This webinar was 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 FACT community will learn a lot together over the coming months, and 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 was the first webinar in the Quality Management Series, Module 7.

Conducting Validation Studies for Shipping of Cells (ISCT), September 7, 2016
Learning objectives:

  • Understand regulatory requirements and principles of the validation of the procedures
  • Designing a validation study for shipping of cells
  • Discuss examples of validation case studies
  • Considerations for international shipping

Navigating the FACT Accreditation Process (FACT), April 6, 2016
Description: The purpose of this webinar held on April 6, 2016, is 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.

NetCord Webinar: Quality Risk Management (NetCord), March 8, 2016
Description: This webinar was live on March 8, 2016. 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.

Quality Organization Virtual Roundtable (FACT), February 10, 2016
Description: This webinar was live on February 10, 2016. The presenters gave an overview of how their organizations set up a Quality Management program and maintain a culture of quality in the organization. This webinar was the last session in the Quality Management Series Module 6: The Quality Organization.

Quality Management Overview (FACT), January 13, 2016
Description: This webinar was live on January 13, 2016. Dr. Robert Rifkin, Member, Cellular Therapeutics Department, gave an overview of Quality Management principles and elements. This webinar was the third session in the Quality Management Series Module 6: The Quality Organization.

Organizational Self-Assessments (FACT), October 14, 2015
Description: This webinar was live on October 14, 2015. 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.

Organizational Structure and Charts (FACT), August 26, 2015
Description: This webinar was live on August 26, 2015. 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. This webinar was the first session in the Quality Management Series Module 6: The Quality Organization.

Lessons Learned to Effectively Transition to the FACT 6th Edition Cellular Therapy Standards – Virtual Roundtable (FACT), June 17, 2015
Description: This webinar was live on June 17, 2015. Presenters shared their experience and success with transitioning to the 6th Edition of Cellular Therapy Standards.

Virtual Roundtable: Quality Management of Facilities (FACT), May 11, 2015
Description: This virtual roundtable was live on Monday, May 11, 2015. The Quality Management Committee hosted a panel of three accredited organizations who shared their methods of quality management of facilities.

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.  

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As a Matter of FACT

The FACT accreditation program is a peer-review process.

Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more