Upcoming Educational Events
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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
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
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.
