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ISCT-AABB Quality Agreement Template Now Available

  

ISCT and AABB are pleased to offer our members access to a new jointly created ISCT-AABB interpretive tool to assist in the development of a Quality Agreement. This Quality Agreement may be used with external entities that perform critical services including procurement, manufacturing, testing and administration of a cell/tissue product.

In the field of biotherapy, agreements with external entities to perform critical services have become more commonplace. Such relationships are defined through the use of a Service Agreement and a Quality Agreement. Quality Agreements identify and describe key quality and regulatory responsibilities between the client and the service provider.
 
The Quality Agreement Template outlines scope of work, deliverables, timelines to clearly define expectations between parties and responsibilities regarding Quality Assurance, Quality Control and Quality Risk Management.

ISCT-AABB Quality Agreement Project Team 
The formation of the team is the result of a collaboration between the International Society for Cell & Gene Therapy (ISCT) and the Association for the Advancement of Blood & Biotherapies (AABB) who develop projects of mutual interest in a joint ISCT-AABB workgroup (WG).

Diane Kadidlo, MT(ASCP), SBB

Project Co-Leader

Facility Director, Molecular and

Cellular Therapeutics

University of Minnesota

St. Paul, MN

Mary Grable McLeod, MLS(ASCP)CM SBBCM, SSGB (ASQ), CABP(H)

Project Co-Leader

Quality Manager – Blood and Marrow

Transplant Cellular Therapy Facility
Stanford Hospital and Clinics

Stanford, CA

Brenda Alder, MS, MT(ASCP)SBB, CABP(H)

Cell Therapy Transplant and Tissue Bank

QA and Regulatory Manager,

Northside Hospital

Peachtree Corners, GA

Aisha Khan, PhD, MBA

Executive Director Of Clinical Research

& Laboratory Operations

University of Miami

Miami, FL

Aleksandra Babic

Senior Manager Quality Assurance

Site Qualification and Regional

Operation Quality ACE and International,

Kite Pharma a Gilead Company

Singapore, Netherlands

Sufira Kiran, BS, CQA, MLS

Associate Director of Quality Assurance

Research

Manufacturing at UTHealth Science Center

University of Texas Health Science Center

Houston, TX

Suzanne Dworsky, BS,CABP(H),MBA, MT(ASCP)

Medicine Department Administrator,

Stem Cell Transplantation and Cellular

Therapy

MD Anderson Cancer Center

Houston, TX

Diana Nordling

Director Quality Assurance Regulatory

Affairs, Transplant Services/Cell Therapy

Hoxworth Blood Center

Cincinnati, OH

Jelena Holovati, PhD

Associate Professor, Director, Edmonton Stem Cell Manufacturing Program,

Canadian Blood Services

Department of Laboratory Medicine

& Pathology

Division of Medical Laboratory Science

University of Alberta

Alberta, Canada

 

William Shingler, PhD, MBA

Senior Director, Patient and Cell

Management

Autolus

London, UK


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