Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating ...
The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the ...
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 ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
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 ...
Regulatory, analytical, and process concerns must be taken into account. Process validation (PV) is the collection and evaluation of data from the process design stage through commercial production ...
An updated version of Valida-tion Instruments for Community Pharmacy has been published. The book is authored by Claire Scicluna, Lilian Azzopardi and Anthony Serracino-Inglott from the University’s ...
Approved by the Royal Society of Chemistry for purposes of continuing professional development (CPD). The course will provide you with the requisite scientific knowledge and understanding of ...
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