QP Pharmaceutical Law and Administration
To help assure patient safety, the manufacture and distribution of pharmaceutical products is highly regulated.
The Qualified Person (QP) must ensure that all legislative obligations are fully satisfied before any product is certified and released for sale or supply in countries where manufacturing has occurred or where the product will be distributed.
This requires a thorough knowledge and understanding of UK and relevant EU Laws related to the manufacture, storage and supply of medicinal products for human and veterinary use.
This course provides a comprehensive overview of the requirements of the UK Study Guide and demonstrates, via interactive questions and scenarios, how the QP, can assure compliance.
This course is also applicable to other personnel who want to keep up to date with the pharmaceutical industry legislation.
Interested in QP training for your team? Contact us today.
This is an essential course for candidates who expect to apply for their QP VIVA.
It is ideal for Continuing Professional Development (CPD) for existing QPs as well as all other managers or supervisors with responsibilities for manufacturing medicinal products.
This course is also useful for those not directly involved in manufacturing as it provides a valuable overview of the regulatory framework for the control of medicines manufacture and supply.
This course includes the following topics:
UK and EU introduction and legislative processes
Manufacturing Authorisations
Product/Marketing and Clinical Trial Authorisations
Role of the UK MHRA, EMA and VMD
Overview and application of the Orange Guide
Management of complaints, defects and recalls
Import, Export and Distribution
Mutual Recognition Agreements (Delegate pre-work)
Product labelling
PIC/S and ICH
Ph Eur and BP
Role of EDQM and certification procedure
Pharmacovigilance
Supply chain scenario
At the end of the course you will understand:
The UK laws and relevant European Directives for the manufacture and distribution of medicinal products for human and veterinary use
Clinical trial legislation
Product and site licensing in the UK
Role and structure of the MHRA, EMA, and VMD
Structure and application of the Orange Guide
Management of complaints, defects and recalls
Requirements for import, export and distribution
International harmonisation, ICH, PIC/S and mutual recognition agreements
Product label and leaflet requirements
The role of the pharmacopoeias and EDQM
Pharmacovigilance requirements
The legal responsibilities of the QP and how they are discharged.
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 Pharmaceutical Law and Administration 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 Pharmaceutical Law and Administration 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 Pharmaceutical Law and Administration course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the QP Pharmaceutical Law and Administration 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 two day Pharmaceutical Law & Administration 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.
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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
