PROFESSIONAL TRAINING
BY INDUSTRY EXPERTSResponsible Person training
for pharmaceutical professionals
Helping you expand and maintain your RP skillset
SeerPharma UK considers our RP training to be the bedrock of many of our customers’ careers. We therefore devote considerable time in finessing these courses to meet the many different ways an RP is required to operate across the Pharmaceutical sector.
We know too that responsibilities never remain the same and as the sector evolves, we not only refine our core offer, the Gold Standard 4 day RP course and the Gold Standard Multi-format 3 day RP course, but we run a valuable Responsible Person Refresher course. This course is not just a reprise of the Gold Standard course, it is an opportunity to expand your skillset.
All our courses are up-to-the-minute in terms of course content (including regulatory focus) and offer the unique insight of the former MHRA Inspectors who build and run these courses.
Furthermore, if you want to expand your skillset yet more, or your company wishes to explore greater opportunities, we offer an RP Import course covering procurement and supply of medicinal products from abroad.
Have a look through the course descriptions below for our range of RP courses. And if you cannot quite find the course that has the focus you need, talk to us about developing a bespoke course that can meet your precise and unique circumstances.
Free explainer article
Between a rock and a regulatory place
Changing the perception of RPs from Revenue Preventers to Revenue Providers
•••••••
This article looks at the opportunity benefits of an element of compliance, the periodic assessment and documentation of the effectiveness of learning.
Click here to read>>
RP Gold Standard
Remote learning
4 Day Course
Description
This course is the most widely accepted core learning for the Responsible Person (RP). It is accredited and certificated by Cogent and recognised by the MHRA
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• The only “Gold Standard” course delivered by former MHRA GDP Inspectors
• Both online and classroom courses were the first to be accredited by Cogent and recognised by MHRA
• The course runs over four days allowing plenty of non-screen time for self-study periods, learner collaboration and opportunities to catch up on the ‘day job’
• Engaging exercises, workshops and case studies
• Delegates receive a copy of the PQG GDP Monograph and a pdf copy of the slides
• On-line support from the presenters for the duration of the course and afterwards
Course Objectives
• Provide the Responsible Person with challenging, realistic and thought-provoking learning opportunities
• Enable the RP to support the licence holder effectively in demonstrating compliance with the WDA
• Encourage the RP to question their role in maintaining the integrity of the medicinal product supply chain
• Provide a supportive learning environment with a range of experts and peers
Expected Learner Outcome
• New ways to improve and demonstrate compliance and management of risk
• Develop knowledge and skills in GDP and the applicable regulations
• Confidently face the day-to-day challenges of this demanding role
• Understand the inspector’s approach
• Communicate with third parties with increasing confidence in own knowledge
• Incorporate this greater understanding in effective delegation
• Apply the learning to the quality system
Special features
• Former MHRA Inspector led sessions and exercises
• Practical, pragmatic approach to training, using real-world examples
• Interactive learning approaches, with open questions
• Self-assessment throughout the course to increase confidence in learning
• All delegates will receive comprehensive course documentation
• Post-course assessment
• Certificate of Completion issued by Cogent
Training audience
The Training Course is designed for new RPs, prospective RPs, experienced RPs, QPs and other quality, logistics and supply chain personnel
“The course was absolutely fantastic! The content and delivery of the course was comprehensive, well organised, thought-provoking which kept me engaged and learning throughout. The wealth of knowledge and experience of the trainers was evident and greatly disposed to delivery of the training. Thank you!”
RP Gold Standard
Multi-format
3 Day Course
Description
All the benefits of face-to-face teaching and remote teaching. Yes, after all this time spent over Zoom and Teams you will have the opportunity to meet real people, in person. Interaction and learning exercises will be more productive in the classroom setting.
The course content is exactly the same as the remote course we have been running but the time spent face-to-face will be more immersive. This three-day course comprises two full days and two half days. We have retained some remote elements and it is expected that you will stay away from home one night. The remote sessions allow plenty of opportunity for you to catch up on the day job. For those who cannot travel, or who choose not to, there will be the option to dial into the classroom sessions.
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• The only “Gold Standard” course delivered by former MHRA GDP Inspectors
• Both online and classroom courses were the first to be accredited by Cogent and recognised by MHRA
• The course runs over four days allowing plenty of non-screen time for self-study periods, learner collaboration and opportunities to catch up on the ‘day job’
• Engaging exercises, workshops and case studies
• Delegates receive a copy of the PQG GDP Monograph and a pdf copy of the slides
• On-line support from the presenters for the duration of the course and afterwards
Course Objectives
• Provide the Responsible Person with challenging, realistic and thought-provoking learning opportunities
• Enable the RP to support the licence holder effectively in demonstrating compliance with the WDA
• Encourage the RP to question their role in maintaining the integrity of the medicinal product supply chain
• Provide a supportive learning environment with a range of experts and peers
Expected Learner Outcome
• New ways to improve and demonstrate compliance and management of risk
• Develop knowledge and skills in GDP and the applicable regulations
• Confidently face the day-to-day challenges of this demanding role
• Understand the inspector’s approach
• Communicate with third parties with increasing confidence in own knowledge
• Incorporate this greater understanding in effective delegation
• Apply the learning to the quality system
Special features
• Former MHRA Inspector led sessions and exercises
• Practical, pragmatic approach to training, using real-world examples
• Interactive learning approaches, with open questions
• Self-assessment throughout the course to increase confidence in learning
• All delegates will receive comprehensive course documentation
• Post-course assessment
• Certificate of Completion issued by Cogent
Training audience
The Training Course is designed for new RPs, prospective RPs, experienced RPs, QPs and other quality, logistics and supply chain personnel
RP Refresher Course
(with an emphasis on transactions)
Description
A project-based course delivered by former MHRA inspectors.
It begins with a ‘taught’ session covering key Quality Management System tools and principles, allowing collaboration with other industry professionals.
You then have a choice of projects to complete in your own time over the subsequent weeks. Your allocated trainer will review the work and provide necessary feedback. Where appropriate, projects may be done with support from your line manager and/or in collaboration with other candidates.
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Key topics
• A focus on licence holder obligations and RP authority and responsibilities
• Demonstrating continued knowledge and experience to the inspector
• Defining the scope of outsourced activities and ensuring effective control
• Understanding product types to engage all staff in the fight against falsified medicinal products
• Practical applications of data integrity within GDP
Course Objectives
The Responsible Person must keep up-to-date with their knowledge and experience. This can be particularly challenging in a pressured work environment. The course will provide opportunities to meet those challenges and the ‘difficult to implement’ areas by tapping into the experience of the former MHRA inspector. The activities are intended to focus on carrying out the role effectively and in demonstrating compliance to the inspector.
Expected Course Outcome
• The Responsible Person will be more confident in implementing activities that are not well described in GDP but are compliance expectations
• The Licence Holder will be able to demonstrate meeting the requirements of Regulation 45
• Learners will have the opportunity to discuss their learning with other industry professionals
• All course attendees will have the opportunity to ask questions from former MHRA inspectors – in relation to the course material, or in more general terms, relating to the wholesale of medicinal products
Special features
• MHRA & Pharma industry experience with in-depth session & workshops
• All delegates will receive comprehensive course documentation.
• Certificate of Attendance issued by the trainers.
• Hands-on Case studies & practical examples
• Interactive learning approach, with open questions
Training audience
The Training Course is of particular interest to the experienced Responsible Person; but is also suitable for other Quality Personnel and Supply Chain Personnel.
“I learnt more from this training than any other RP Refresher Course I’ve attended and I enjoyed discussing thoughts on the exercises both in the break out room sessions and the wider group.”
RP Import Course
Description
Ensuring compliant and effective procurement and supply of medicinal products from approved countries.
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Key topics
• Roles and responsibilities of the Responsible Person Import
• Responsible Person Import Person Criteria
• Implementation Period
• Documenting your supply chain (exercise)
• Systems and processes to implement changes (exercise)
• Transportation of medicinal products
Course Objectives
More detailed look at the changes required for the importation of medicinal products from the approved country list and the role of the RPi. Topics covered will provide a more detailed insight into the activities associated with the role and the group work sessions help further clarify requirements and changes needed to introduce the RPi role into your business. Course will also look at the supply chain to Northern Ireland.
Expected Course Outcome
• Help you further understand your supply chain and make effective changes.
• Help you learn how the changes in regulations affect your organisation.
• Help you to understand how to incorporate the role of the RPi.
Special features
• MHRA & Pharma industry experience with in-depth session & workshops
• All delegates will receive comprehensive course documentation.
• Certificate of Attendance issued by the trainers.
• Hands-on Case studies & practical examples
• Interactive learning approaches, with open questions
Training audience
The Training Course is of particular interest to Responsible/Designated Persons but also Management, Quality Personnel and Supply Chain Personnel.
“The knowledge and experience that is exclusive to MHRA Inspectors is passed on to the delegates and makes this course unique and invaluable, in my opinion.”
Free explainer article
Between a rock and a regulatory place
Changing the perception of RPs from Revenue Preventers to Revenue Providers
•••••••
This article looks at the opportunity benefits of an element of compliance, the periodic assessment and documentation of the effectiveness of learning.
Click here to read>>