QP Role and Professional Duties
A Qualified Person (QP) must certify that each batch of medicinal product (for human or veterinary use) complies with its Marketing Authorisation or Clinical Trial Application, GMP and other specific requirements. Their conduct overall must comply with the Code of Practice for Qualified Persons which defines the standards of conduct and good practice for the QP.
While the QP may not have direct line responsibility for many of the activities which could affect compliance, they must be aware of any information, incidents or deviations which may influence their decision to certify whether a batch is compliant and subsequently suitable for release.
This course provides a comprehensive overview of the requirements of the UK Study Guide and, using interactive questions and scenarios, demonstrates how the QP can comply with the legal and operational requirements of the role.
Interested in QP training for your team? Contact us today.
The module is essential for all candidates who expect to take the QP VIVA, while also forming a valuable contribution to Continuing Professional Development (CPD) for QPs who qualified a while ago and would benefit from updating their knowledge.
Other managers and supervisors from within pharmaceutical manufacturing would also gain from attending this course through acquiring a thorough understanding of the relationship of the QP with their own role.
The course includes the following topics and group exercises:
Annex 16 knowledge check
Overview of the role and duties of the QP, product lifecycle and associate authorisations
Clinical trials and QP declaration for IMPs
QP in development, technology transfer and commercial manufacture
Management of unexpected deviations
Challenges of being a contract QP
QP declaration for active substances
Imports and exports post Brexit
Role of ICH and VICH
Preparation and management of regulatory inspections
Role of QPPV and interaction with GMP QP
Role of QP in complaints and recalls
QP application process
Regulatory inspections
By the end of the course the attendee will understand:
The legal responsibilities of the QP within the UK and EU
The Code of Practice for the QP
The role of the QP during the stages of the product lifecycle
The regulatory framework pharmaceuticals in the UK and EU/EEA
QP declarations
The certification process for a medicinal product according to Annex 16
The impact of Brexit.
The QP and the Pharmaceutical Quality System (PQS)
Interaction between the QPPV and the GMP QP
How to deal with typical product problem situations
Preparing for and conducting inspections
QP application process
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, 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 Role and Professional Duties 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 Role and Professional Duties 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 Role and Professional Duties course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the QP Role and Professional Duties 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 Role and Professional Duties 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 Role and Professional Duties 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
