Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational ...

To help teams fully realize these benefits, the following at-a-glance reference reinforces the core ASTM packaging standards ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a ...

Real world analysis of VTE incidence in lung cancer: A comprehensive assessment of the Khorana score and other clinical factors in predicting VTE incidence. This is an ASCO Meeting Abstract from the ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...

Simply put, orthogonal validation uses additional methods that provide very different selectivity to the primary method to confirm or refute a finding. All methods are independent approaches that can ...