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

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

From early research to quality control, maintaining analytical continuity is no easy task. Could a single sequencing workflow help simplify analytical assessment?

Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan–Treated Human Epidermal Growth Factor Receptor 2–Positive ...

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...

Learn how viral vector release testing for AAV and lentiviral vectors utilizes orthogonal assays for titer, capsid content, ...

The key statistical objective in IVD device evaluation is establishing performance criteria while minimizing bias and maximizing precision. While the statistical considerations and methodologies ...

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 ...