You might often want to validate parameters in your methods to ensure they have valid data. Most importantly, you might often want to protect your publicly exposed API methods by ensuring that the ...

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

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 ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

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

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Dany Lepage discusses the architectural ...

Last week, Jeff Fredrick and I did a day-long code review of Platypus. We used a pair-programming approach, with Jeff driving and I helping with the navigation. Eventually, we got into the input ...