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 ...

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 ...

Multiple reaction monitoring-mass spectrometry became a mainstream method for quantitative proteomics, which made the validation of a method and the analyzed data important. In this portal for ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

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 ...

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 ...

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

Carfilzomib, a second-generation proteasome inhibitor, is widely used in the treatment of multiple myeloma. This synthetic tetra-peptide epoxyketone derivative binds irreversibly to the 20 S ...

Advanced analytical services support partners from product characterization and assay development to GMP readiness and clinical manufacturingIntravacc offers state-of-the-art analytical methods for ...