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.
The course covers the following topics :
- What is the basis for GMP inspections and what may trigger them?
- Legislation & Guidelines available
- The inspection Process
- Practical tips on how to prepare thoroughly for any GMP inspection
- Guidance on how to manage the actual inspection; including potentially difficult situations
- Details on how to follow up from an inspection – e.g. what is required in the response?
- How to maximise your chances of a successful inspection and achieving the desired outcome
By the end of this course you will have gained :
- Understanding the Inspection process from the regulator’s viewpoint
- Aware of how to prepare carefully for a GMP inspection and what can be in scope
- Understand some of the practical challenges of managing an inspection and how these can be successfully overcome
- Feel more confident when interacting with inspectors and answering their questions
- As trainee QPs, gain an awareness of a specialised area of compliance within GMP