How to be agile in the dynamic regulatory environment without sacrificing quality – Best practices for CLIA lab setup and certification

The Clinical Laboratory Improvement Amendments require that clinical laboratories, including those in healthcare facilities, reference labs, public health labs, and some research labs need to be certified. Many practices for developing Laboratory Tests (LDTs) and establishing a new functioning laboratory are common to CLIA certification and FDA approval. CLIA certification is a first step toward FDA companion diagnostic kit approval. During this session, you will learn:

• How to set up a CLIA laboratory that meets CLIA standards
• Actions to take to be prepared for an inspection
• Best practices for laboratories to implement that will enable them to be ready for regulatory changes

Meeting Details:

Nov. 9, 2023

 5:00 – 8:00 pm

 2400 Barranca Parkway, Irvine CA

Refreshments and soft drinks will be provided

COST: Free for OCRA Members & Students, $15 Non-Members

Featured Speaker

Linda Castle, Senior Consultant

Integrated Project Management Company, Inc

Linda Castle is a Senior Consultant with Integrated Project Management Company, Inc. (IPM), a national consulting firm focused on providing solutions to complex problems and ensuring strategy realization through disciplined project leadership. She has a long career as a scientist and manager in Life Sciences, leading discovery, new technologies, and product development biotech laboratory teams. She has been a certified project manager focusing on CLIA laboratories for the past seven years, where she has led LDT development and launch, tech transfers, lab construction, operational efficiency, and fast-paced laboratory stand-up projects.

Linda has bachelor’s degrees in math and forest science and a PhD in genetics. She is a certified Project Manager (PMP), a SAFe Agile Scrum Master, and a Six Sigma/LEAN Greenbelt.

Questions? Contact Fawn Zhang: (206) 639-1311; fawnzhang0@gmail.com

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