Course Overview
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.
Who Should Attend
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.
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.
Who Should Attend
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.
