A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…