Lab Quality Resources, LLC-About Us

Whether your laboratory has short term quality goals or is in need of a quality system
“make over”, Lab Quality Resources, LLC has the knowledge and proven experience
to take you to the next level.

Direct laboratory experience includes over 20 years of veterinary, human
embryology, andrology, clinical endocrinology, and bioassay development. Past
accreditation, certification and laboratory related inspection experience includes Food
and Drug Administration (FDA), Clinical Laboratory Improvement Act (CLIA), College
of American Pathologists (CAP), Joint Commission for the Accreditation of Hospital
Organizations (JCAHO), American Association of Tissue Banks (AATB), and American
Board of Bioanalysis (ABB).

Past cGMP (FDA, ICH, EU) QA and QA management experience includes contract
biopharmaceutical manufacturing, bioassay laboratory techniques in addition to
implementing cGMP (to supplement GLP) in molecular biology laboratories. More
recently, projects have included Quality System Plan development and execution,
validation activities and the development of medical device cGMP Quality Systems.
This broad range of experience and success has been based on the same basic
Quality System principles that Lab Quality Resources, LLC can customize to fit your
needs.

Typically large consulting companies charge sizeable fees for what seem to
be “universal template” procedures, plans, and training sessions. They may
not take into account how your business, and the regulations you are to comply with,
must not only assure the quality of your laboratory functions/results, but also not
impede upon the efficiency or productivity of your laboratory service!

Lab Quality Resources, LLC focuses on the relevant regulations as they
apply to YOUR laboratory and will provide tools (gap analysis, pre-
inspection/ remedial action plans, training, procedures) with YOUR business
in mind.