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 ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...
What will you learn on this course? This course looks at method validation from start (initial planning) to finish (on-going tracking of performance statistics). Starting with describing the end goal ...
In a recent editorial published in Current Pharmaceutical Analysis (Volume 18, Issue 6, 2022), researchers Dr. Behrouz Seyfinejad and Dr. Abolghasem Jouyban highlight the importance of method ...
In-line UV spectroscopy allows real-time monitoring of cleaning processes, enhancing process control and compliance with Pharma 4.0 goals. The method provides continuous detection of residual cleaning ...