AABB Series 3
Duration: 1 Hour
Dec 1, 2021
To access content, click on each session title in red below.
AABB Quality Series 3 - Session 1 - Validation Principles, Processes, and Equipment Qualification
During this session we will cover the following topics:
- Differentiate validation from verification, qualification and calibration
- Describe process and equipment validation
- Recognize the phases of equipment validation
- Give examples of validation steps in IQ, OQ, PQ
AABB Quality Series 3 - Session 2 - Equipment Operation and Performance Qualification
During this session we will cover the following topics:
- Describe equipment OQ and PQ
- Discuss the differences between OQ and PQ
- Give examples of validation steps in OQ and PQ
These educational activities are brought to you by Ortho Clinical Diagnostics and are certified for continuing medical education after viewing of all three sessions and completion of the survey on demand. The views and opinions expressed are those of the speakers. Please consult all instructions for use and current intended use for products referenced during these presentations. This program is sponsored by Ortho Clinical Diagnostics and the speaker must present information in accordance with applicable U.S. Food and Drug Administration (FDA) requirements. The audience is reminded to consult all instructions for use and current intended use for products referenced during the presentation.
About Our Speakers:
About Our Speakers:
Jack Hager, MS, MT(ASCP)SBB
AABB Quality Consultant
New Braunfels, TX
Jack A. Hager MS, MT(ASCP)SBB is a certified Medical Laboratory Scientist and Specialist in Blood Bank who has worked in hospitals, blood centers and testing laboratories his entire career. He retired from the US Air Force Biomedical Corps as a Lt Colonel and subsequently was Laboratory Director and CEO of the American Red Cross, National Testing Laboratory in Portland Oregon.
Jack has more than 30 years of experience in transfusion medicine and infectious disease testing. He was until recently Vice President of Operations for one of the largest blood and plasma testing laboratories in the US, which provides testing for blood centers and major drug therapeutic manufacturers. Most recently, he opened Community Labs, San Antonio, a non-profit laboratory that provides free and low-cost PCR-based COVID testing for asymptomatic people in and around San Antonio, TX.
Jack was a 2017 recipient of the ASCP Member Excellence in Management Award. This award is given to an individual who demonstrated effective leadership skills and management strategies, and whose contributions to laboratory quality improvement have inspired their colleagues. He is also currently a member of The George Washington University School of Business Customer Experience Program Advisory Council.
Jack A. Hager MS, MT(ASCP)SBB is a certified Medical Laboratory Scientist and Specialist in Blood Bank who has worked in hospitals, blood centers and testing laboratories his entire career. He retired from the US Air Force Biomedical Corps as a Lt Colonel and subsequently was Laboratory Director and CEO of the American Red Cross, National Testing Laboratory in Portland Oregon.
Jack has more than 30 years of experience in transfusion medicine and infectious disease testing. He was until recently Vice President of Operations for one of the largest blood and plasma testing laboratories in the US, which provides testing for blood centers and major drug therapeutic manufacturers. Most recently, he opened Community Labs, San Antonio, a non-profit laboratory that provides free and low-cost PCR-based COVID testing for asymptomatic people in and around San Antonio, TX.
Jack was a 2017 recipient of the ASCP Member Excellence in Management Award. This award is given to an individual who demonstrated effective leadership skills and management strategies, and whose contributions to laboratory quality improvement have inspired their colleagues. He is also currently a member of The George Washington University School of Business Customer Experience Program Advisory Council.
About Our Speakers:
Gary Griffin, MS, MT(ASCP), SBB
AABB Quality Consultant
Houston, TX
Gary received his Bachelor of Science in Medical Technology from Arkansas State University, Ark, received a Master of Science in Immunology from Bowling Green State University, Ohio, and attended the Executive Management Program, Partners in Organizational Leadership, Center of Creative Leadership at Harvard University, Cambridge, MA.
Certified by the American Society of Clinical Pathology, as a Medical Technologist and Specialist in Blood Banking. He has also achieved the Certified Quality Manager/Organizational Excellence certification and Biomedical Auditor, from the American Society of Quality.
Positions held include: US Army Clinical Laboratory Officer; attended the Armed Services Blood Bank Fellowship, Washington, DC. Served multiple Blood Bank Officer positions in US Army, including Chief of the Armed Services Blood Center, Fort Ord CA, and Chief Blood Bank and Clinical Pathology, Tripler Army Medical Center, Honolulu HI. Other notable positions include Chief of Blood Bank at University of Texas, Galveston, Director of Testing and Executive Officer, American Red Cross National Testing Laboratories, (Charlotte, NC; Portland, OR; and San Diego, CA), and Director of Quality, Cyberonics, Houston TX., Manager of Transfusion Medicine at University of Texas M. D. Anderson Cancer Center, Houston, Tx., Director of Laboratories at QualTex Laboratories, San Antonio, Tx., and Manager of Blood Donor Operations, University of Texas M. D. Anderson Cancer Center, Houston, Tx., and General Partner, Aquarius Innovations, LLC.
He served on the Malcolm Baldrige National Quality Award Board of Examiners and the Quality Texas Foundation Board of Examiners.
Gary received his Bachelor of Science in Medical Technology from Arkansas State University, Ark, received a Master of Science in Immunology from Bowling Green State University, Ohio, and attended the Executive Management Program, Partners in Organizational Leadership, Center of Creative Leadership at Harvard University, Cambridge, MA.
Certified by the American Society of Clinical Pathology, as a Medical Technologist and Specialist in Blood Banking. He has also achieved the Certified Quality Manager/Organizational Excellence certification and Biomedical Auditor, from the American Society of Quality.
Positions held include: US Army Clinical Laboratory Officer; attended the Armed Services Blood Bank Fellowship, Washington, DC. Served multiple Blood Bank Officer positions in US Army, including Chief of the Armed Services Blood Center, Fort Ord CA, and Chief Blood Bank and Clinical Pathology, Tripler Army Medical Center, Honolulu HI. Other notable positions include Chief of Blood Bank at University of Texas, Galveston, Director of Testing and Executive Officer, American Red Cross National Testing Laboratories, (Charlotte, NC; Portland, OR; and San Diego, CA), and Director of Quality, Cyberonics, Houston TX., Manager of Transfusion Medicine at University of Texas M. D. Anderson Cancer Center, Houston, Tx., Director of Laboratories at QualTex Laboratories, San Antonio, Tx., and Manager of Blood Donor Operations, University of Texas M. D. Anderson Cancer Center, Houston, Tx., and General Partner, Aquarius Innovations, LLC.
He served on the Malcolm Baldrige National Quality Award Board of Examiners and the Quality Texas Foundation Board of Examiners.
