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 ...

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for ...

Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards ...

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

(click to enlarge)This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

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 ...