Registration is Open for the FACT Inspection & Accreditation Virtual Workshop!
September 21, 2020 – 8:00 am to 3:00 pm CDT/13:00 to 20:00 GMT
When one door closes, another one opens – and FACT’s first ever Inspection & Accreditation Virtual Workshop makes these words ring true! We wish all of our stakeholders good health and safety, and are pleased to offer a new workshop format to allow us all to come together again. After all, learning never ends.
The workshop co-chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH, have been working hard with the FACT Education Committee and the international panel of presenters to offer an elegant and interactive learning experience. Registrants can choose either the cord blood or apheresis track, and will also have the opportunity to ask questions directly to leaders in accreditation, cord blood, or apheresis in the Lunch with Leaders session.
Following a combination of presentations, recordings, activities, games, and discussions, workshop attendees will leave the event able to:
- Describe the accreditation process.
- Evaluate the documentation to ensure compliance.
- Organize the on-site inspection process.
- Plan a program tour.
- Identify strategies to support a successful inspection.
- Practice evaluating deficiencies.
The year 2020 has made it even more obvious that a culture of quality is critical to providing quality patient care. With no travel required and low registration fees, several colleagues at your institutions can register for the event, thereby developing an even deeper understanding of FACT accreditation at your program.
“See” you at the workshop!
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FACT Professional Relations Committee Provides a Forum for Sharing Experiences in Challenging Year
The cellular therapy community is well known for its spirit of collaboration. One testament to the teamwork enjoyed by the field is the FACT Professional Relations Committee. One of the purposes of this committee is to enhance communications with relevant organizations in the field. This year, 13 organizations are members, and each has nominated a representative to meet at least quarterly to discuss any issues that have captured its attention, new initiatives that might be of interest to other organizations, and requests for input or participation.
Catherine Bollard, MD, inaugural committee chair and Director for the Center for Cancer and Immunology at the Children’s National Medical Center, recently transitioned committee leadership after many years of service to Bruce Levine, PhD, Professor in Cancer Gene Therapy at the University of Pennsylvania. Dr. Levine has called special meetings throughout the COVID-19 pandemic to allow organizations to share ideas, provide updates to processes, and ask questions of each other. The benefits of these discussions were the ability to seek advice and learn from each other, communicate changes impacting cellular therapy programs to a wider audience through multiple channels, and establish some consistency among processes. Topics included, among others, training on caring for transplant patients with COVID-19, cryopreservation of unrelated allogeneic products, virtual meetings, and remote inspections.
FACT thanks the following organizations for their participation on the committee and leadership during this challenging year:
- American Association for Tissue Banking (AATB)
- American Society for Apheresis (ASFA)
- American Society for Gene & Cell Therapy (ASGCT)
- American Society for Histocompatibility & Immunogenetics (ASHI)
- American Society for Transplantation and Cellular Therapy (ASTCT)
- College of American Pathologists (CAP)
- Cord Blood Association (CBA)
- International Society Cell & Gene Therapy (ISCT)
- National Marrow Donor Program (NMDP)
- Standards Coordinating Body (SCB)
- World Marrow Donor Association (WMDA)
FACT Quality Management Series, Module 10: Validations
The Quality Management Series Module 10 includes four sessions focused on Validation including:
- Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT
Dr. Prokopishyn discussed the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.
- Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT
Presenters will discuss 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
- Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT
Dr. Rodwell and Dr. Klamer will discuss 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)
- Vendor and organization responsibilities
- Program Perspective on Validation
Register for the entire module to receive a 15% discount! QM Series Module 10: Validations