A practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection.

Regulatory Inspections are a requirement in the Pharmaceutical industry and as people move on, sometimes the expertise on how to manage these is reduced or lost within specific organisations. In addition, new companies are regularly finding themselves moving towards the situation where a site authorisation is required that will trigger their first GMP inspection and there may be little experience of these within the company.

It is of fundamental importance to ensure the best possible outcome possible so this course will focus on those practical aspects from preparation through to follow-up after the inspection. It will focus on UK MHRA inspections, but also cover US Pre Approval Inspections. It will cover announced, unannounced and for cause inspections.

The course is suitable for those working in Quality Assurance who may find themselves assisting in the preparation for an inspection and possibly also answering questions posed by the inspector or providing support in the back room. It is also of benefit to those who may have less understanding of the requirements/expectations so those in Production, QC, engineering, facilities, validation and IT. It could also be of benefit for trainee QPs who may have limited understanding of the challenges involved but who will be expected to be closely involved when they are a QP named on the site licence.