This bundle of the QM Series consists of sessions related to outcome analysis, specifically related to cellular therapy programs and cord blood banks. Advance registration and post-webinar recordings of the following webinars are included at a discounted rate: 

1. Benchmarking One-Year Survival (November 30, 2016)
2. Completing FACT-Required Outcome Analyses (January 11, 2017)
3. Making Outcome Analysis Work for You (January 25, 2017)
4. Improving Our Clinical Outcomes Virtual Roundtable (February 8, 2017) 

Published February 2016. This QM Series consists of sessions about creating a culture of quality and accountability within the organization, specifically related to cellular therapy programs and cord blood banks. 

The following webinars are included in the bundled series: 

1. Organizational Structure and Charts (August 26, 2015)
2. Organizational Self-Assessments (October 14, 2015)
3. Quality Management Overview (January 13, 2016)
4. Quality Organization Virtual Roundtable (February 10, 2016)

This QM Series bundle consists of document control sessions specifically related to cellular therapy programs and cord blood banks. Handouts and post-webinar recordings of the following webinars are included at this discounted rate: 

1. The Document Control Process From Start to Finish (and Back Again!) (September 13, 2017)
2. Staff Involvement in Document Control: Where do YOU fit in? (January 10, 2018)
3. The Digital Age: Controlling Documents within an Electronic System (January 24, 2018)
4. Virtual Roundtable: Control of Different Types of Documents (August 29, 2018)

This QM Series bundle comprises the auditing process associated with cellular therapy programs and cord blood banks. Handouts and post-webinar recordings of the following webinars are included at this discounted rate: 

1. Planning and Executing the Audit (January 23, 2019)
2. Summarizing and Evaluating the Data (March 6, 2019)
3. Performing Follow-Up to Assess the Effectiveness of the Actions Implemented on Correcting the Errors (June 11, 2019)
4. A Program's Perspective: Auditing (February 5, 2020)

Published: August 19, 2020. Nicole Prokopishyn, PhD, Cellular Therapy Lab Director at Alberta Blood and Marrow Transplant Program: Foothills Medical Centre, Alberta Children's Hospital and Tom Baker Cancer Centre, and Calgary Laboratory Services, discussed the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

1. Learners will be able to differentiate between validation, verification, and qualification in relation to cellular therapy processes.
2. Learners will be able to assess the appropriate quality assurance method (Validation, Verification, or Qualification) to apply in various scenarios within a Cellular Therapy Laboratory setting.
3. Learners will be able to develop a Process Validation plan for their program, incorporating key elements discussed in the webinar.

Are you interested in the entire QM Series 10 on Validations? You can purchase the complete set for a reduced bundle price here: 2020 On-Demand QM Series 10 Bundle.

Published: October 14, 2020. Jacklyn Stentz MT (ASCP), Quality Program Manager at Baylor University Medical Center, and Deborah Griffin, MS, ASQ CPGP, consultant at FACT Consulting, discussed validation processes. At the conclusion of this on-demand webinar, participants should be able to:

1. Define the concepts of Process Validation and Verification as they apply to cellular therapy procedures, including Bone Marrow processing.
2. Differentiate between scenarios requiring Process Validation and those requiring Verification in cellular therapy quality assurance processes.
3. Assess the appropriate range for validation in cellular therapy procedures, considering variables and extreme scenarios to determine where to start and when to stop the validation process.

Are you interested in the entire QM Series 10 on Validations? You can purchase the complete set for a reduced bundle price here: 2020 On-Demand QM Series 10 Bundle.

Published: December 2, 2020. Robyn Rodwell, PhD, MSc (GMP & QM), previous director of the Queensland Cord Blood Bank at the Mater, and Guy Klamer, PhD, from the Sydney Cord Blood Bank, discussed 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. 

At the conclusion of this on-demand webinar, participants should be able to:

1. Explain the role of software validation as a substitute for paper-based systems in critical procedures within cellular therapy facilities, including decision-making, calculations, and information storage.
2. Differentiate between vendors' and organizations' responsibilities in maintaining and validating critical electronic systems used in cellular therapy processes.
3. Assess the suitability of spreadsheets and other critical electronic systems for cellular therapy facilities, considering data integrity, security, and compliance with regulatory requirements.

Are you interested in the entire QM Series 10 on Validations? You can purchase the complete set for a reduced bundle price here: 2020 On-Demand QM Series 10 Bundle.

Published: December 7, 2021. Dr. Joseph Schwartz, MD, MPH, from Mount Sinai Bone Marrow and Stem Cell Transplantation Program, discussed the clinical approach to process and software validation. Jeannette Bloom, MBA, MT(ASCP)SBB, discussed the apheresis and processing approach to validation and software validation from the perspective of the Baylor College of Medicine Stem Cell Transplant program. Walid A. Almashaqbeh BS, BB (ASCP), discussed the cord blood banking approach to validation and software validation from King Abdulaziz Medical City's program perspective.

Are you interested in the entire QM Series 10 on Validations? You can purchase the complete set for a reduced bundle price here: 2020 On-Demand QM Series 10 Bundle.

Published: December 2020. This QM Series consists of sessions related to the validation process associated with cellular therapy programs and cord blood banks. The following webinars are included in the QM Series 10 Bundle on Validation: 

1. Validation Overview (August 19, 2020)
2. Process Validation (October 14, 2020)
3. Software Validation (December 2, 2020)
4. Program's Perspective: Validation (December 7, 2021)

Published: February 16, 2022. The first webinar in the four-part QM Series 11, Dr. Carlos Bachier from Sarah Cannon Transplant and Cellular Therapy Program at Methodist Hospital in San Antonio and Lisa Cantwell, MHA, CPHQ from the Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa, discussed the following: 

1. When a corrective action plan is needed
2. The purpose of a corrective action plan 
3. Who should be involved 
4. Short-term Immediate corrective action and long-term preventive correction action 
5. How to assess the effectiveness of a corrective action plan

Want the complete Quality Management 11 Series on Corrective Action Plans?  Purchase all four webinars here at a discounted price: Foundation for the Accreditation of Cellular Therapy: 2022 On-Demand QM Series 11 Bundle (factglobal.org)