Related Opportunities

 

The Foundation for the Accreditation of Cellular Therapy (FACT) encourages inspectors, transplant programs, and cord blood banks to utilize educational activities to maintain knowledge of industry practices and regulations. FACT assists its constituents with identifying activities that are applicable to their operations and/or training needs with this topical list of opportunities for education. For training specific to the FACT inspection and accreditation process, see the FACT Training Page for more details.

 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. Consult the FACT-JACIE Cellular Therapy Standards or NetCord-FACT Cord Blood Standards, as applicable, for information related to FACT accreditation.

 

QUALITY MANAGEMENT

Validation of Processes (Part 2): Retrospective and Prospective (ISCT, March 2009)
Description: This webinar provides examples of retrospective and prospective validation studies. It addresses the appropriate or significant number of validation trials for a given process, including for staffing challenges and smaller laboratories. (PDF order form for CD recording.)

Validation of Processes (Part 1): Validation and Qualification of Equipment and Reagents (ISCT, February 2009)
Description: This webinar provides overviews, components, and examples of validating equipment and qualifying reagents. (PDF order form for CD recording.)

Qualification of Vendors, Equipment, and Supplies (PACT, January 2009)
Description: This web seminar provides an overview of the processes used at different centers to qualify vendors, equipment, and supplies. Regulatory requirements and approaches to compliance are discussed. (WMV recording.) 

CLINICAL PROGRAMS

Umbilical Cord Tranplantation State of the Science (ASBMT, October 2009)
Description: this seminar uses extensive documentation collected from literature and accumulated experience at the University of Minnesota to show that umbilical cord blood transplantation can be considered a first line choice in treatment of pediatric acute leukemias. This seminar also discusses how such transplants can be advantageous for adults. Outcome predictions are explained based on HLA match, cell dose, and recipient age. (Online registration and viewing.)

Transplantation from Unrelated Donors: Factors That Influence Outcomes and Graft Choices (NMDP, August 2009)
Description: This program discusses the influence of patient and donor factors on unrelated transplant outcomes. (Online registration and viewing.)

Advances in HLA Matching for Unrelated Donor Transplantation (NMDP, August 2009)
Description: This program discusses advances in HLA typing including clinical and technology innovations. (Online registration and viewing.)

Changing Clinical Practice and Predicting the Future: HCT Outcomes from a Pulmonary and Critical Care Perspective (ASBMT, February 2009)
Description: This online seminar discusses bronchiolitis obliterans syndrome (BOS) in the hematopoietic cell transplant population, including how deriving a pre-transplant assessment of mortality (PAM) can help identify the potential for post-transplant clinical problems. (Video podcast.)

Allogeneic Peripheral Blood Stem Cell Transplant vs Bone Marrow Transplant of Hematological Malignancies (ASBMT, January 2009)
Description: This online seminar discusses significant detail from published research studies that conclude that bone marrow and peripheral blood produce different products, including a meta-analysis to determine which product is better for a particular disease and for what reasons. (Video podcast.) 

COLLECTION FACILITIES

Apheresis Support of Stem Cell Transplant (ASFA, January 20, 2010 at 12 pm ET)
Description: This webinar will highlight the advances and challenges in the collection and infusion of HPCs for transplantation, discuss the roles of apheresis for preparing patients and marrow HPC products for transplantation, and review indications for therapeutic apheresis procedures for posttransplant complications and patient responses. (Online registration form.)

Automated Collections FDA Guidance Documents (ASFA, February 24, 2010 at 12 pm ET)
(Online registration form.)

Management of Poor Stem Cell Mobilization, Updates on New Stem Mobilization Agents (ASFA, March 10, 2010 at 12 pm ET)
(Online registration form.)

ISCT Webinar Provides Industry Perspective on FDA Inspections (ISCT, October 2009)
Description: The presenters discuss how to prepare, manage and successfully complete GMP/GTP regulatory inspections. They also present their real-life experiences in handling FDA inspections in their own facilities. (PDF Order form for CD recording.) 

Current and Future Apheresis Applications in Cell Therapy the Focus of ASFA Webinar (ASFA, December 2009)
Description: This webinar reviews current applications of cellular therapy with an emphasis on expansion into a variety of medical specialties, discusses the technologies used to support the manufacture of cellular therapies, and considers future directors of cellular therapy. (PDF Order for for CD recording.) 

Technical Aspects of Donor Management, Donor Apheresis, Automated Donor Collection, and Collecting Multiple Products (ASFA, July 2009)
Description: This webinar compares the various automated devices in terms of multiple products produced and the donor eligibility parameters of those devices. A comparison or risk of donor adverse events between automated and whole blood collections and considerations in comparing cost of operations per multiple and component product produced is also provided. (PDF order form for CD recording.)

Stem Cell Collections (ASFA, March 2009)
Description: This webinar discusses the purpose of peripheral blood stem cell collections; large volume peripheral blood stem cell collections; and the use of anticoagulant, minimizing and treating citrate toxicity and electrolyte disturbances. (PDF order form for CD recording.)

Regulatory Issues: Information Sharing Regarding FACT (ASFA, June 2009)
Description: This webinar reviews common deficiencies cited during FACT inspections and changes to the Standards in the fourth edition. (PDF form for CD Recording.)

Cell Therapy: An Overview of Current & Future Applications (ASFA, December 2009)
Description: This webinar reviews current applications of cellular therapy with an emphasis on expansion into a variety of medical specialties and consider future directions of cellular therapy. (PDF form for CD Recording.)

 PROCESSING FACILITIES

ISBT 128 Update (ISCT, February 2010)
Description: ISCT will host a webinar which will provide participants information regarding the current status of the global initiative for ISBT 128 labeling of cellular therapy products. A facility with one year of operational experience with ISBT 128 will provide insight on how to overcome the hurdles of implementing ISBT 128 labeling for a multi-site BMT program; describe and review the labeling system design process, implementation, and validation; and discuss current issues and challenges.

Sterility Testing for Cellular Therapy Products (ISCT, November 2009)
Description: This webinar mentions the most recent regulatory requirements for sterility testing on cellular therapy products, outlines the different methods to perform the testing, and describes validation methods for both manual and automated procedures. (PDF Order form for CD recording.)

Stability Testing and Optimization - Considerations for Cell Therapy Products (ISCT, September 2009)
Description: This webinar promotes understanding of requirements for stability testing in cell therapy, and how to establish a stability testing program. It also discusses methods and technologies for optimizing stability and preservation of cells, tissues, and cell therapy products. (PDF order form for CD recording.)

2009 College of American Pathologists Survey Education (CAP, 2009)
Description: Surveys education activities are intended for staff from laboratories who participated in select CAP Surveys products. These activities are available for CE credit only and are designed to reinforce concepts and discussion points related to the associated Surveys product. These activities include a specified reading in the Participant Summary or Final Critique and online learning assessment questions with immediate feedback. Select the associated Surveys product for which you would like to complete the online education activity. (Online registration.)

 

REGULATIONS

Distribution of Unrelated Manipulated Cord Blood In or To the U.S. after October 20, 2011, a Domestic and International Perspective (ISCT, December 2009)
Description: This webinar discusses the high and low points of the FDA's guidance documents on unrelated allogeneic cord blood licensure and INDs, the basics of unrelated allogeneic rod blood licensure, and the distribution of cord blood when licensure requirements are not met. (ISCT Webinar page.)

FDA Inspections for Cell Therapy Products from the Perspective of Hospitals and Industry (ISCT, October 2009)
Description: This webinar discusses how to prepare, manage and successfully complete GMP/GTP regulatory inspections. The presenters share

Interpretation of the Final Rule: cGMP and Investigational New Drugs Intended for Use in Phase 1 Clinical Trials (PACT, October 2009) 
Description: This webinar provides an overview of the Final Rule and its implementation in the manufacture of cellular therapy products. Regulatory requirements and approaches to compliance are discussed. (WMV Recording.)

Deviation Management of Type 351 & 361 Cell Products (PACT, July 16, 2009)
Description: This web seminar will provide an overview of the regulatory pathways for reporting manufacturing and/or testing deviations in Type 351 and 361 products. Product deviation management scenarios will be presented and discussed.

Batch Records for Cellular Therapy Products (ISCT, April 2009)
Description: This webinar describes the concept of batch process manufacturing versus continuous process manufacturing. It explains the requirements of the FDA with respect to batch processing records (BPR) and how they can serve as a guidance for creating a facility’s own BPR. (PDF order form for CD recording.)