Management of GMP inspections

2 Day/s

CPD Hours: 14

Classroom, online, in-house

Are you filled with apprehension when a GMP Inspection is on the horizon? Does the mere thought of navigating through GMP Inspections leave you feeling stressed and uncertain? Are you seeking enhanced support from your colleagues to tackle the intricacies of GMP Inspections effectively? If you resonate with these concerns, then our course on the Management of GMP Inspections is tailored to address your needs.

It is vital that pharmaceutical companies plan carefully for all Good Manufacturing Practice (GMP) inspections, as a successful outcome is required for continued operations. It is of fundamental importance to manage the entire process to ensure the best outcome possible. This course will focus on those practical aspects from preparation through to follow-up after the inspection. It will focus on UK MHRA inspections and their approach to the whole inspection process.  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.

This course is essential learning for personnel working in quality, at all levels, whether in quality compliance, quality systems, quality operations or any other quality related role. It will also be of great benefit to other functions involved in a GMP inspection, including but not limited to Production, Quality Control, Engineering/Facilities, Vendor Assurance, and IT. The course could also be beneficial 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.

Learn all about GMP Inspections, using the UK approach as the model, so you can be as well prepared as possible and be able to effectively manage any undesired outcomes covering such topics as:

  • 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 
  • 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

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Bring this course in-house

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Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Sue Mann

Sue has run her own consultancy since 2009 and works with companies all around the world. She became a QP in the mid 1980’s and a QP Assessor in the early 2000’s. Although her core knowledge and experience is in GMP, she has built up knowledge and experience in Good Distribution Practice (GDP) and has helped write a guidance document published by PQG and ECA which expands upon the EU GDP Guideline. Sue has dealt with many GMP systems in her over 40 years’ experience in the industry; including WHO whilst involved in a development project in a number of African countries, funded by UNIDO. Sue has been a QP for many years and understands the complexity of the role and its position within a company. She is an inspiring trainer being able to break down complex topics into understandable sections and can “train” at all levels in an organisation. She understands what it is that is important in fulfilling the role of a QP.

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