Preliminary Workshop Agenda - Factweb.org

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11 Sep 2013 ... Carolyn Taylor, PhD. 11:15 am. Lunch. Introduction to Cell Therapy. Processing Facilities Track. Inspections Track. 11:45 am. Clinical ProgramĀ ...
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