This is an intensive course covering FDA and USP <1010> MHRA and the European draft guidances for OOS.

It covers an in-depth review of investigations of laboratory OOS.

A review of different factors that can be introduced into practice that can reduce the amount of OOS’s created in the laboratory.

The course will go beyond the laboratory phase and examine issues that can arise in production that can cause OOS and the special requirements of OOS in the R&D environment.

It will also examine OOS and some aspects of OOT and OOE in stability testing, scale up and during validation and describe general principles of how to carry out an investigation including both hard and soft skills.