Learn from the people who know
All our courses are built and overseen by former MHRA inspectorsThree great RP courses to keep your career skills on track
Responsible Person
“Gold Standard”
4 Day Training
Responsible Person
Refresher
1 Day Training
Responsible Person
Import
1 Day Training
RP Gold Standard Course
4 day
£1750
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.
Key topics
• 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
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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
LinkedIn SeerPharma Closed Group Members contact debra.stanfield@seerpharma.co.uk
Outside the UK? Contact debra.stanfield@seerpharma.co.uk for VAT-free registration.
“It was a fabulous interactive course with great material and brilliant presenters that kept me interested all the way through. I feel confident with the knowledge I have gained to commence my RP role.”
RP Refresher Course
1 day
£649
Description
A one-day course presented by former MHRA inspectors face-to-face over Zoom. The agenda will address those areas the Responsible Person typically finds difficult to implement. A key focus will be maintaining the integrity of the supply chain. The course is not a re-cap of GDP but an opportunity to expand the skill-set.
Each course is similar in content but will run with a different emphasis, detailed in the description. The course will have entirely new content in 2022.
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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.
LinkedIn SeerPharma Closed Group Members contact debra.stanfield@seerpharma.co.uk
Outside the UK? Contact debra.stanfield@seerpharma.co.uk for VAT-free registration.
“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
1 day
£649
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
• Course will help you further understand your supply chain and make effective changes.
• Course is designed to help you learn how the changes in regulations affect your organisation.
• Course will 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.
LinkedIn SeerPharma Closed Group Members contact debra.stanfield@seerpharma.co.uk
Outside the UK? Contact debra.stanfield@seerpharma.co.uk for VAT-free registration.