Responsible Person

Course Overview

Our 3-day Cogent Gold Standard Responsible Person (RP) training course prepares individuals for the RP role under EU Good Distribution Practice (GDP) guidelines. This programme holds Cogent approval and meets their training standards for trainee Responsible Persons.

The course covers the roles and responsibilities of an RP to help ensure that the end user receives medicinal products that have been controlled, stored and transported correctly. The course includes the requirements of Good Distribution Practice (GDP) and the legal responsibilities of an organisation holding a Wholesale Dealers Authorisation (WDA) to ensure that products are purchased and sold within the legal supply chain. During the course we cover the specific requirements for the correct transportation, storage and distribution of medicinal products as well as the need to have a well designed Quality Management System (QMS) with a focus on compliance and continual improvement.

Cogent Gold Standard

The course is approved by Cogent and meets their training requirements

Dates available to book

This course is available for in-house presentation, either on-site or virtually. Please contact us for further details.

Who will the course benefit?

This Responsible Person training course is aimed at people who want to become a Responsible Person, as well as individuals involved in the procurement and sale of bulk medicines, including Wholesale Dealers Authorisation holders. The course is also of value as part of Continuous Professional Development of existing RPs. In addition, the course will be of value to Qualified Persons (QP) who need a detailed appreciation of GDP and the role of an RP. The course is also of value to people who are involved in the selection of organisations involved in the storage and transport of finished products, as well as supplier auditors who audit such organisations.

For a foundation in GDP before taking this course, see our Good Distribution Practice course (1 day, £600 + VAT).

Course Contents - Day 1

The roles and responsibilities of the Responsible Person (RP)

Day 1 covers the regulatory foundations of pharmaceutical distribution, from the history of medicines regulation through to the specific requirements of GDP and the Responsible Person role:

Preliminaries

Introductions and welcome. Course objectives. Review of programme, training methods and timings.

The Regulation of Medicines

  • The history of the regulation of medicines
  • How you get a new medicine to market
  • The importance of product quality
  • An introduction to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
  • The importance of the legal supply chain
  • The UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
  • The rules concerning the manufacture sale and supply of medicines in the UK and the EU
  • The UK’s Medicines Act (1968) and rules issued since then
  • The MHRA’s “Green Guide”
  • European Union (EU) Directives and regulation, including Eudralex
  • The European Medicines Agency (EMA)

What is Good Distribution Practice (GDP)?

  • The structure of GDP
  • The main requirements of GDP
  • The Responsible Person
  • The link between the Responsible Person (RP) and a Qualified Person (QP)
  • EXERCISE: What does GDP say?

What is the Responsible Person (RP)?

  • The legal responsibilities of the RP
  • The availability of the RP and delegation rules and guidelines
  • Interactions with Senior Management and the WDA holder
  • How do you become a Responsible Person (RP)?
  • Skills and experience necessary to become an RP in the UK
  • The Cogent Gold Standard
  • The impact of BREXIT
  • The RPi

Premises and Equipment

  • Facility design and operation
  • Access and security
  • Pest Control and cleaning
  • Different storage areas for products
  • Temperature and environmental control and monitoring
  • Thermal mapping of facilities
  • Dealing with temperature excursions
  • Use of computer-based stock control systems

The WDA and becoming an RP

  • Structure of the WDA and the application/variation process
  • Qualifications, skills and experience required to become an RP & RPi
  • Creating training plans for RP personnel development and CPD
  • What do you need to do/know as the RP within your organisation?

End of day review

Review of the day. Preview of day 2. Discussion and questions.

Course Contents - Day 2

Day 2 moves from regulatory theory to operational practice. How GDP requirements apply to day-to-day warehouse, transportation, and supply chain activities:

Review of Day 1 and Introduction to Day 2

Recap of yesterday and programme for today.

Operations

  • Supplier and customer approval and ongoing review
  • The EUDRA and other databases
  • Control of goods-in and goods-out – the legal supply chain
  • Goods-in and receipt of materials
  • Inspection of incoming materials
  • Ensuring the correct storage of materials
  • Sale and dispatch of goods
  • Picking and packing of materials
  • Control of returns and rejected stock
  • The Falsified Medicines Directive (FMD)

Outsourcing

  • Subcontractor selection
  • Quality Technical Agreements
  • Monitoring and review of performance, including supplier audits

Transportation

  • Supply Chain Mapping and integrity including modes of transport and transport lane validation
  • Risk mitigation
  • Maintenance of product storage conditions during transport
  • Validation of temperature control and monitoring
  • Use of freight forwarders
  • Export and import processes
  • Customs procedures and national laws

Validation, qualification, change control, maintenance and calibration

  • The reasons for validation and qualification and the key stages involved
  • The importance of change control
  • The importance of premises and equipment maintenance
  • Requirements for calibration of measuring equipment

End of day review

Review of the day. Preview of day 3. Discussion and questions.

Course Contents - Day 3

Day 3 focuses on the Quality Management System. How to establish, document, monitor and continuously improve the QMS that underpins your GDP operations:

Review of Day 2 and introduction to Day 3

Recap of yesterday and programme for today.

The Quality Management System

  • GDP’s requirements for a Quality Management System (QMS) and the role of the RP within that QMS
  • The role of Senior Management
  • How to establish a QMS

Documentation and records

  • Key documents of a QMS
  • Documentation and record requirements of GDP
  • Keeping records, including transactions and invoices
  • Data integrity requirements

People and training

  • GDP’s requirements for the training of personnel
  • Clothing and hygiene requirements
  • Monitoring the effectiveness of training
  • Training records

Complaints and recalls

  • Dealing with complaints and communication of complaints to other people involved
  • The Recall Process and the RP

Problems, Deviations and CAPAs

  • Dealing with problems and deviations
  • Getting to the root-cause of the problem and dealing with this
  • Correction, Corrective Action and Preventive Action
  • Quality Risk Management

Monitoring, review and improvement of the QMS

  • Method to review the performance of the QMS
  • Internal audits
  • Review of metrics and quality data
  • Management Review
  • Improvement mechanisms

What next

Actions for delegates on their journey to become an RP.

Closing Session

Discussion and questions. Course evaluation.

Frequently asked questions

Is this course Cogent Gold Standard accredited?

Yes. Our Responsible Person training course holds Cogent Gold Standard accreditation. The industry-recognised benchmark for pharmaceutical distribution training in the UK. The course is approved by Cogent and meets their training requirements for trainee Responsible Persons.

How long is the course?

This is a three-day intensive course delivered as a live online interactive programme. Day 1 covers the regulatory framework, GDP requirements, and the RP role. Day 2 focuses on operations, transportation, and supply chain management. Day 3 covers the Quality Management System, documentation, and continuous improvement.

Will I receive a certificate?

Yes. All delegates receive a course attendance certificate upon completion. The course is CPD-relevant for current and aspiring Responsible Persons.

Can I become a Responsible Person after completing this course?

This course provides the training and knowledge required for the RP role, based on the Cogent Gold Standard requirements. To be named as an RP on a Wholesale Distribution Authorisation (WDA) licence, you also need to demonstrate relevant practical experience and meet the UK skills and experience requirements. The course covers the qualification pathways in detail.

What are the prerequisites?

The course is designed for individuals aspiring to become a Responsible Person, as well as current RPs seeking CPD. It is also suitable for Qualified Persons needing detailed GDP understanding, procurement personnel, WDA holders, and supplier auditors. No formal prerequisites are required.

Is there a refresher course for existing Responsible Persons?

Yes. Our Responsible Person Refresher course is a one-day programme covering the latest GDP requirements and regulatory updates. It is designed as an essential CPD for working RPs.

What is the difference between RP and RPi?

A Responsible Person (RP) is named on a Wholesale Distribution Authorisation and oversees GDP compliance for pharmaceutical distribution. A Responsible Person for Import (RPi) has additional responsibilities for the importation of medicinal products, particularly relevant since Brexit. We offer a separate RPi training course (half day, £395 + VAT) for those needing import-specific training.

Can this course be delivered in-house?

Yes. This course is available for in-house presentation, either on-site or virtually. Please contact us to discuss your requirements.

What’s included?

The cost includes:

  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.
Course Cost

£1695 per delegate plus VAT *. Course will be charged in GB pounds.
* Delegates from outside the UK, but within the European Union (EU) will not be charged 20% VAT (sales tax), if they supply their own company’s national VAT number when booking. Please select “Tax exempt” when booking and enter your company VAT number. VAT will not be charged for any delegates coming from outside the UK or EU.

Payment

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this training course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Based outside the UK

If so, be sure to pick the ‘Tax Exempt’ options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

Group Booking Discount

Book 2 or more individuals from the same company for the same course date to get a 10% discount off each booking.  This discount is applied automatically when you make a booking.  If you are from an NHS organisation or a registered charity, then please contact us for special discounts.

Course Times

Responsible Person training course:

Each day: 09.00 – 16.30 (UK time).  Includes 15 minutes break in morning and afternoon, plus 45 minutes for lunch.

What is involved?

We will send you a link to the live online interactive course with your joining instructions once you have booked your place.

You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware  correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

Meet the expert tutors

Susan Navarro

Susan Navarro

Emma Holmes

Emma Holmes

Dominic Parry

Dominic Parry

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Get in touch

+44 1635 866699

info@inspiredpharma.com

Inspired Pharma Training Ltd,

5 Westbrook Court, Sharrow Vale Road,

Sheffield, S11 8YZ, United Kingdom.