Beyond the Checkmark: Mastering the Arts of Qualification and Validation

Qualification and validation of processes and products are important in the quality assurance programs of an eye bank. Speakers will discuss qualification and validation, defining each process and highlighting how they are different from each other. Jerry Burkey, from San Diego Eye Bank, discusses how to write and execute an equipment qualification, providing a template. Vivian C. Lopez, from Beauty of Sight, provides information on how to conduct a process validation for a new process and will use tissue preparation for CAIRS as an example.

Attendees will learn:

Templates for qualification and validation of processes
How to write and execute an equipment qualification
New process validation for CAIRS tissue preparation

Learn more about qualification and validation; register for this presentation today!

CEUs: 1 CEU will be awarded for this session

Jerry Burkey, CEBT

Quality Assurance Lead

San Diego Eye Bank

Jerry Burkey, CEBT, is a Certified Eye Bank Technician and the Quality Assurance Lead at the San Diego Eye Bank. Prior to working in Eye Banking, Jerry was a Fire Chaplain and Executive Director at FirefighterAid. He has 15 years of experience in eye banking across various disciplines, having worked in Recovery, Quality, Hospital Development, and Donor Eligibility. Jerry currently serves on the EBAA QA Committee and the Technical Procedures Manual Subcommittee.

Vivian Lopez

Quality Assurance Director

Beauty of Sight Eye Bank

Vivian Lopez has a BS in Biology and is the QA Director for the Beauty of Sight Eye Bank, located at the Bascom Palmer Eye Institute in Miami Florida. She has more than 30 years of combined experience in quality control operations, research and development, data analysis, equipment qualifications, process validations and establishing quality management systems. She has worked in different FDA regulated industries such as Biotechnology, Diagnostics, Medical Device and in Eye Banking for the past 14 years.

Elizabeth Ellett, MSHA, MT(ASCP), CQA(ASQ), ACHE (Moderator)

Vice President of Regulations and Compliance

Advancing Sight Network

Elizabeth R. Ellett, MSHA, MT(ASCP), CQA(ASQ), ACHE, is the Vice President of Regulations and Compliance at Advancing Sight Network. Elizabeth received her Master of Science in healthcare administration from the University of Alabama at Birmingham (UAB). Elizabeth holds certifications with the American Society of Quality, American Society of Clinical Pathologist, and Lean Six Sigma as a Green Belt. She has served as both lead and general auditor for CAP and AABB and is a current member of American College of Healthcare Executives.