CLSI QSRLDT
Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Edition
This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part.
This report is available in electronic format only.
Member price:
List Price:Details
Chairholder: Corrisa Miliander; Shannon Bennett, MS, MBA, CMQ/OE (ASQ)
Date of Publication: September 16, 2024
Order Code PDF: CLSI QSRLDTEd2E
ISBN Number: 978-1-68440-248-9
Order Code Print: print not available
Edition: Second
Pages: 130