Risk assessment tools

There are several trainings and fancy tools out there on different risk assessment methods. But there are also good materials on ICH webpage as a briefing pack. You can easily extract the knowledge you are after from these presentations.

Recent Posts

See All

Deviation management - how to capture our event the best way?

Several different guidelines, laws are mentioning requirements about deviation management, but mostly about the essence of classification, identifying the true root cause, etc. But it's not described

Periodic reviews - what to use them for?

PQR, QMR, CPV, VMP/VMR, Computerized systems' periodic reviews, who knows what else...we manufacture these summaries, but exactly what for? Sometimes we spend so much time compiling these documents th

Retest period or shelf-life?

I just received a question that looked easy at first, but the laws and guidelines are surprisingly vague on this topic. The question is: how to choose between retest period and shelf-life for an API (