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 ...
Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...
The key market opportunities lie in providing training for analytical method validation, focusing on drug substance and product analysis. This includes lab procedure transfer techniques, compendial ...
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 ...
Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.
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, ...
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