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 ...

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 ...

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. The words ‘method’ and ‘validation’ do not ...

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 ...

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s ...

Approved by the Royal Society of Chemistry for purposes of continuing professional development. This course will provide you with the requisite scientific knowledge and understanding of analytical ...

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 ...

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 ...