In this Issue

Accreditation Statistics

As of August 1, 2023

Cellular Therapy Entities

  • Accredited: 255
  • Applicants: 26

Cord Blood Banks

  • Accredited: 53
  • Applicants: 9

Congratulations to the following organizations for achieving initial accreditation:

Pennsylvania Hospital, Penn Medicine: Adult autologous hematopoietic progenitor cellular therapy, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

Sarah Cannon Transplant & Cellular Therapy Program at MountainView Hospital: Adult autologous hematopoietic progenitor cellular therapy, immune effector cellular therapy administration, peripheral blood cellular therapy product collection, and cellular therapy product processing with minimal manipulation

A complete list of accredited organizations can be found at www.factglobal.org.

Upcoming Educational Events

Posted in :: 2020 Volume 6 :: Friday, August 21st, 2020

Register now:

Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance

 

Upcoming Quality Management Series Module 10: Validation

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

Register now

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)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation

TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview

Presented by Nicole Prokopishyn, PhD

August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

FACT Announces New Quality Management Series, Module 10: Validations

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

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 will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

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

Register now

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)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire module to receive a 15% discount! QM Series Module 10: Validations