To provide the cellular therapy community with important educational content, FACT will continue hosting virtual events until it is safe to resume in person meetings. We are excited to announce two events in February 2021: a FACT Inspection and Accreditation Workshop and a FACT-ASTCT Quality Boot Camp.
FACT Inspection and Accreditation Workshop
February 4, 2021
This virtual workshop is on Thursday, February 4, from 7:30 am – 4:30 pm CT, 13:30-22:30 GMT. Applicants interested in accreditation are invited to this interactive workshop. Information will interest initial applicants and those who have attended previously.
Additional workshop content will include common citations, data management, clinical outcome analysis, and an update on FACT virtual inspections.
• Describe the accreditation process.
• Evaluate documentation to ensure compliance.
• Organize the on-site inspection process.
• Plan a program tour.
• Identify strategies to support a successful inspection.
• Practice evaluating deficiencies.
• Prepare for a FACT Virtual Inspection.
• Identify significant changes to the eighth edition Cellular Therapy Standards.
• Summarize the expectations of inspectors and applicants for data management.
• Utilize tools to evaluate outcome data.
Attend an optional lunch session with two FACT-accredited programs who will share how FACT accreditation is beneficial while managing the COVID-19 pandemic.
FACT-ASTCT Quality Boot Camp
February 5, 2021
Join us for the 2021 FACT-ASTCT Quality Boot Camp: Navigating a Changing Environment Using Quality Systems.
Discuss and explore core quality concepts throughout the day and learn how to apply those concepts to an example. “Adding immune effector cells to program services” will be used to illustrate concepts learned and navigate components of the quality system from beginning to end, including:
- Perform a Facility Needs Assessment
- Develop a Change Control
- Execute Risk Assessments
- Determine what to Validate and Audit
- Perform Validation(s)
- Establish Quality Indicators
- Perform Audits
At the end of the day, boot camp participants will be able to apply learned concepts to their own program needs when adding or changing components to their program.