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 will discuss 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)
- Spreadsheets
- Vendor and organization responsibilities
Program Perspective on Validation
TBA
Register for the entire module to receive a 15% discount! QM Series Module 10: Validations
