QP Investigational Medicinal Products
All Quality Persons (QPs) need to understand the different Good Manufacturing Practice (GMP) requirements for commercial and Investigational Medicinal Products (IMPs), and the unique additional GMP requirements required for IMPs. This two-day interactive course examines the EU legislation relevant to the manufacture, control and supply of IMPs. It provides practical guidance on the major differences in the GMP requirements between IMPs and commercial products and the unique areas that QPs need to consider when releasing IMPs (e.g. packaging and labelling processes and control).
The course also provides an insight to the registration, establishment and conduct of clinical trials to Good Clinical Practice (GCP); how clinical trial design impacts IMP manufacturing operations and the significance of the GMP/GCP interface.
This course now has an optional eLearning Knowledge Reinforcement Module available for delegates to purchase at £170. The eLearning module reviews 5 key topics from the tutor led course and has 72 questions to test your knowledge and ensure learning retention in preparation for your VIVA.
Interested in QP training for your team? Contact us today.
This is an essential course for all those who are undergoing QP training and expect to be undertaking the QP VIVA. The course is also suitable to those wishing to ensure they have sufficient awareness of the specific nature of IMPs and the challenges facing the QP. It is suitable for QPs, production and QA staff working in IMP manufacture and supply.
The course includes the following topics and group exercises:
Purpose of clinical trials
Law governing clinical trials
Ethics in clinical
Application process for clinical trials
Clinical trial design
Manufacture of IMPs
Clinical trial master file
Interpretation of clinical trial protocol
Packaging, labelling and randomisation
Breaking the trial protocol
Introduction to Annex 13
QP certification of IMPs
At the end of the course you will:
Understand the requirements of Directives 2001/20/EC, 2005/28/EC and 2003/94/EC
Understand the accompanying UK clinical trial regulations S.I. 2004/1031
Understand the key points regarding EU Clinical Trial Regulation 536/2014 and the impact on the UK
Recognise the regulatory and ethics approval processes for clinical trial authorisation
Appreciate the unique nature of many aspects of IMP manufacture
Understand the relationship between clinical trial design and IMP packaging
Understand the key principles of GCP
Be aware of the GCP/GMP interface and the unique GMP requirements for IMPs
Understand the responsibilities of the QP for the registration, manufacture of IMPs for clinical trial
Recognise the important relationship between the Sponsor and the QP.
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
| Yes, QP Trainee packages are available with RSSL and include a number of exclusive benefits. Contact our QP Training Advisor to learn more on trainingsales@rssl.com or by calling +44 (0)118 918 4000, and join our upcoming webinar, 'To QP or not to QP?', designed for aspiring QPs. |
| Yes, the QP Investigational Medicinal Products 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 QP Investigational Medicinal Products course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-funding 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 QP Investigational Medicinal Products course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the QP Investigational Medicinal Products 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. |
| Usually, this 2-day QP Investigational Medicinal Products course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000. |
| Our online QP Investigational Medicinal Products course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course. For our in-person courses, refreshments are available from 08.30am, for a 09:00am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later. 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. |
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
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
