Performing Risk Assessment to Establish Inspection Methodology
This presentation will provide a detailed review in the evaluation of tissue bank risk assessments in regard to auditing and inspection.
Michelle Lewis, BA, ASQ CBA, RAC, CTBS
Michelle has 20+ years in biologics, drugs, medical devices, and HCT/P’s. Currently, she is the Accreditation Assessment Manager for AATB providing post-inspection support for CAPA responses and inspection reports; serves as the primary liaison with the Accreditation Committee and the NonTransplant Anatomical Donation Council; a key member of the Standards committee and helps drive policy changes within the Accreditation and Standards department. Michelle came to the association after many years of building her expertise in the field of regulatory compliance and auditing.
Sabrina Qualley, BA, MLT(ASCP), CTBS, CQA (ASQ)
Sabrina has 30 years of experience in blood and tissue banking. She is a Certified Quality Auditor, a Certified Tissue Banking Specialist and has a Medical Laboratory Technician degree. Sabrina has been performing accreditation inspections as an independent contractor for AATB for 9 years. Prior to that, she was the Quality Program Manager for the tissue program at LifeCenter Northwest, the QC Specialist at Northwest Tissue Center, the Lead Operational Tech for the Islet and Cell Processing Laboratory at Puget Sound Blood Center, and started her career in the transfusion service (cross-match and red cell reference laboratories) of Puget Sound Blood Center.