11 Sep 2013 ... Carolyn Taylor, PhD. 11:15 am. Lunch. Introduction to Cell Therapy. Processing
Facilities Track. Inspections Track. 11:45 am. Clinical Program ...
Cellular Therapy Inspection & Accreditation September Workshop 11, 2013
ISCT North American Regional Meeting
Morning Session
Agenda
8:00 am Welcome Phyllis Warkentin, MD 8:30 am Following the Accreditation Process in FACTWeb Ramona Repaczki-Jones, MSE 10:15 am
Break
10:30 am
Common Citations
11:00 am
Mock Inspection Videos
11:15 am
Lunch
Karen Snow, BS, (ASCP) BB, CQA(ASQ) Carolyn Taylor, PhD
Introduction to Cell Therapy Inspections Track
Processing Facilities Track
11:45 am Clinical Program Inspections Phyllis Warkentin, MD
Laboratory Controls Karen Snow, BS, (ASCP)BB, CQA(ASQ)
12:30 pm
Collection Facility Inspections Supplier and Materials Qualification Phyllis Warkentin, MD Carolyn Taylor, PhD
1:15 pm Processing Facility Inspections Meeting FACT Standards when Processing with More than Minimal Manipulation Karen Snow, BS, (ASCP)BB, CQA(ASQ) Deborah Griffin, MS 2:00 pm Quality Management Programs Carolyn Taylor, PhD
Validation Studies Phyllis Warkentin, MD
Afternoon Session 2:45 pm
Break
3:00 pm Preparing Cord Blood Units for Administration Christel Skaer, Mayo Clinic Rochester 4:00 pm Expert Panel Deborah Griffin, MS; Ramona Repaczki-Jones, MS; Karen Snow, BS, (ASCP)BB, CQA(ASQ); Carolyn Taylor, PhD; Phyllis Warkentin, MD 4:30 pm
Adjourn
