It is very important for pharmaceutical companies to plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. Careful management of the entire inspection process will also help ensure a successful outcome. 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.
This is a highly practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection. It is suitable for any company or NHS site with a site authorisation associated with any activities involved in the manufacture of medicinal products.
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.
This is a highly practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection. It is suitable for any company or NHS site with a site authorisation associated with any activities involved in the manufacture of medicinal products.
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.
