[Webinar] Putting the Validity in Laboratory Validations: Best Practices for Validation Plan Design and Implementation (Online CE Course)

Author: Alec Saitman, PhD, DABCC (CC, TC)
Reviewer: Laurie Bjerklie, MA, MLS(ASCP)CM

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 235 CE courses, most popular
$109Add to cart
Pick Your Courses
Up to 8 CE hours
$55Add to cart
Histology CE Package$69Add to cart
Histology CE User Increase$69Add to cart
Individual course$25Add to cart

See all available courses

Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 1.5 hour(s)
Approved through 1/31/2028
Florida Board of Clinical Laboratory Personnel Credit Hours - Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1.5 hour(s)
Approved through 1/31/2028

Objectives

  • Describe the regulatory requirements when validating non-waived testing.
  • Define each experiment (such as precision, accuracy, and linearity) in terms of its purpose in an assay validation.
  • Determine which validation experiments need to be completed to comfortably release an assay for clinical use.
  • Design validation protocols that balance regulatory requirements along with logistical, technical, and time constraints.

Additional Information

Level of Instruction: Basic
Intended Audience: Medical laboratory scientists, medical laboratory technicians, laboratory supervisors, and laboratory managers. This course is also appropriate for MLS and MLT students and pathology residents.
Author Information: Alec Saitman, PhD, DABCC (CC, TC) is currently the Technical Director of the LabCorp Core Laboratory in Portland, Oregon. His research focuses on the development of small molecule quantitation assays using mass spectrometry. His areas of interest include laboratory stewardship and laboratory informatics. He is particularly interested in establishing efficient test implementation workflows in toxicology testing to meet the growing testing demands in his laboratory. Dr. Saitman completed PhD training in total synthetic organic chemistry at the University of California, San Diego. Dr. Saitman then went on to complete fellowship training in Clinical Chemistry and Toxicology in the Department of Pathology at the University of California, San Diego. He is board certified by the American Board of Clinical Chemistry (ABCC) in Clinical Chemistry and Toxicological Chemistry. He also serves as a CAP inspection leader and inspector and has been involved in many CAP inspections of large reference laboratories.
The author has no conflict of interest to disclose.
Reviewer Information: Laurie Bjerklie, MA, MLS(ASCP)CM, is currently an Education Developer for MediaLab and LabCE. She earned a B.S. in Medical Laboratory Science from the University of North Dakota and an M.A. in Curriculum and Instruction from Saint Xavier University. She has over 15 years of experience in higher education and has held program director and faculty positions in both MLT and MLS programs.

How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 235 CE courses, most popular
$109Add to cart
Pick Your Courses
Up to 8 CE hours
$55Add to cart
Histology CE Package$69Add to cart
Histology CE User Increase$69Add to cart
Individual course$25Add to cart