This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...

Blood was collected from a group of healthy volunteers with informed consent in the registered phlebotomy centre of the Paterson Institute for Cancer Research, Manchester, UK. Plasma was immediately ...

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 ...

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 ...

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 ...

In highly regulated industries, quality and validation procedures can be make or break, and getting them right requires working with system integrators who have industry-specific experience. My first ...

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