Management of GMP inspections
Are you filled with apprehension when a Good Manufacturing Practice (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 GMP inspections, as a successful outcome is required for continued operations. This highly practical course covers the management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection.
This training will focus on UK MHRA inspections and their approach to the whole process, looking at announced, unannounced and for cause inspections.
It is suitable for any company or NHS facility with a site authorisation associated with any activities involved in the manufacture, packing, labelling etc of medicinal products.
Interested in GMP inspection training for your team? Contact us today.
This course is essential learning for personnel working in quality at all levels. 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 GMP inspections, but who will be expected to be closely involved when they are a QP named on the site license.
This course covers the following topics:
The basis for GMP inspections and what may trigger them
Legislation and guidelines
The inspection process
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:
An understanding the inspection process from the regulator’s viewpoint
Be aware of how to prepare carefully for a GMP inspection and what can be in scope
An understanding of some of the practical challenges of managing an inspection and how these can be successfully overcome
Confidence when interacting with inspectors and answering their questions
As trainee QPs, an awareness of a specialised area of compliance within GMP
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
Yes, the Management of GMP inspections course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen Management of GMP inspections course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the Management of GMP inspections course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Management of GMP inspections course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Yes, this Management of GMP Inspections course is available in-person or virtually on the Adobe Connect training platform. If a venue is listed against your preferred course date, then this course is scheduled as an in-person session.
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you.
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
