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 ...

Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...

• Analytical method validation quality standards, touching on MCERTS and ISO 17025 as examples, leading in to an introduction to method accreditation Various case studies are used throughout the ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Market opportunities include providing training for analytical method validation, offering services for the transfer and verification of analytical procedures, developing compendial coordination ...

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 ...

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

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...