Just the FACTs 2021 Volume 4

Posted in :: 2021 Volume 4 :: Wednesday, July 14th, 2021

A hallmark of a strong quality culture is the concept of continuous quality improvement. At FACT, we embrace that spirit and are always open to opportunities to improve our Standards, our inspection and accreditation processes, and the cellular therapy field as a whole. There are many examples of these types of activities within this newsletter.

We extend our sincerest appreciation to our volunteer Standards Committee members, volunteer inspectors, and accredited organizations for their tireless efforts this year. Two months ago, we published the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards. It is always a labor of love. This edition was obviously no exception given the chaos of the past year; however, the committee did not deter from its work to revise and update our Standards. Both inspectors and accredited organizations alike explored the unknowns of virtual inspections. Not only have these inspections gone well, but we have implemented process improvements that have been discovered via the virtual inspection process.

Finally, please identify ways in which you can participate in the many efforts to harmonize industry requirements. You have the direct experience and expertise to leverage decades of lessons learned and accomplishments so that newer cellular therapies can experience the same growth and success as transplant. One such example, applying to be part of the standards working group on industry requirements for apheresis collection, is due by the end of this week.

Sincerely,

Catherine Bollard, MD
FACT President