This course is for all non-commercial sector professionals working on trials subject to GCP inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).  This one-day introductory/intermediate level course is offered in 2 parts. The morning session concentrates on organisational issues arising within R&D department and therefore all categories of R&D staff are strongly recommended to attend. The afternoon session concentrates on issues specific to investigator sites and all members of the site staff as well as pharmacists and lab staff will find this of benefit. R&D staff should attend the full day as they will need to help and advise site staff prepare for inspections.