How do you know when to stop optimising your analytical method? This question was asked during one of the training sessions I was giving. Although…
Quality by design (QbD) is a concept that has become firmly established in the pharmaceutical and biotechnology world. The ICH, FDA and EMA have been…
Risk analysis is an integral part of working in the pharma and biotech industry. The ICH Q9 guideline describes exactly what it is used for…