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.

This is a face-to-face course; the course content is exactly the same as the remote course we present.

Course timetable

Before the course: Optional pre-reading and self-assessment quiz

Tuesday 9.00 to 17.00: Morning - interactive learning including a break with refreshments. Lunch (included). Afternoon - interactive learning including a break with refreshments

Overnight at hotel (can be pre-booked at preferential rates)

Wednesday 9.00 to 17.00: Morning - interactive learning including a break with refreshments. Lunch (included). Afternoon - interactive learning including a break with refreshments

Wednesday evening: 6.30pm (time subject to change) course dinner (included in your booking - 3 courses with a choice of options), evening Q&A sessions in the bar with former MHRA inspectors (optional)

Overnight at hotel (can be pre-booked at preferential rates)

Thursday 9.00 to 16.00: Morning - interactive learning including a break with refreshments. Lunch (included). Afternoon - interactive learning including a break with refreshments.

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
Engaging exercises, workshops and case studies
Delegates receive a pdf copy of the PQG GDP Monograph and a pdf copy of the slides
Support from the presenters for the duration of the course

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-life 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
Upon successful completion of course registration and assessment, a MHRA-supported certificate 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.

Prices

Prices are displayed without VAT. VAT will be added at the point of registering for a course.

Location

Mercure Manchester Piccadilly, Portland Street, Manchester M1 4PH - Mercure Manchester Piccadilly | 4 Star Hotel - ALL (accor.com)

The hotel is a 5-minute walk from Piccadilly Train station and has its own car park. Separately the hotel has a NCP located directly underneath the building.

Attendee well-being

SeerPharma UK puts your health first. It is important to us that all attendees and tutors can participate in a healthy environment. We ask to be informed of any infections or contagious illnesses occurring within 48 hours of course start date.

The course timetable will be amended, and price reduced, if we have to change to online presentation due to any restrictions imposed. We will endeavour to do our best to run the course in the intended format.

Responsible Person "Gold Standard" Face to Face Training