DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added ...

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 ...

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 ...

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, ...

Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...

The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...

Over the last 20 years the Nuclear Science and Instrumentation Laboratory (NSIL, formerly NSAL and Instrumentation Unit) has played a leading role worldwide in the effective use of nuclear ...

Analytical procedures have increasingly become important when conducting audit on financial statements. This has been shown by the Auditing Standards Board, which made it compulsory to perform ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...