Responsible person and GDP cogent approved

3 Day/s

CPD Hours: 21

Classroom, online, in-house

Cogent gold standard

RSSL has been providing Responsible Person training since 2012. Our latest Cogent Gold Standard Approved online and classroom courses incorporate the very latest regulatory aspects, best practice, customer and industry input. 


About the Cogent Gold Standard Approved status, "Cogent Skills alongside the MHRA have developed a new Gold Standard role profile for Responsible Person in Medicinal Products which in turn has led to the agreement of a training standard which is recognised by the MHRA."

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This course has been designed for people who are seeking to be named as a Responsible Person on a Wholesale Dealers Licence (WDA). However, the content is also relevant in the education of those who are involved in the procurement and sale of medicinal products, including Wholesale Dealers Authorisation holders. Similarly 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 will find this course beneficial to enhance their knowledge of what to expect during site visits.

Existing RP’s may also find the course is a valuable part of their Continuous Professional Development particularly those who have performed the role for a number of years. If you are a Qualified Persons (QP) who needs a detailed appreciation of GDP and the role of an RP or maybe looking to be named as an RP, but concerned that you don’t have the depth of knowledge required then you will be most welcome and may find the interactive nature of the course of significant benefit.

The course includes the following topics and reinforced using group exercises :
  • Day 1
    • Expectations to become a RP
    • About the RP
    • Brief history of GDP
    • Regulatory background
    • MHRA and it's role
    • What does GDP cover and the license types
    • The WDA(H) and how to apply
    • License checks EudraGMDP & MHRA GMDP
    • Key personnel in the supply chain and GDP
    • The RPi
    • Brexit
  • Day 2
    • Chapter 1 - Quality Management and it's tools
    • Chapter 2 - Personnel and the role of the RP
    • Chapter 3 - Premises and Equipment
    • Chapter 4 - Documentation
    • Chapter 5 - Operations
    • Chapter 6 - Complaints, returns, suspected falsified medicines & recalls
  • Day 3
    • Chapter 7 - Outsourced activities
    • Chapter 8 - Self-inspection and regulatory inspections
    • Chapter 9 - Transportation, Containers, Packing & Labelling
    • products requiring special conditions
    • Import & Export
    • Chapter 10 - Specific provisions for brokers
    • Controlled drugs
    • Specific provisions for the RP
    • RP in the organisation
    • responsibilities for the WDA holder
    • Parallel distribution
    • Assessment/Test

    Attending this course will ensure that you :


    • Understand the role of the Responsible Person (RP) with respect to personal responsibilities and to that of the employing company or agent and of the importance of patient and the product user safety
    • Understand the legislation and licensing requirements applicable to the wholesale distribution of medicinal products and the role of the RP, with a particular focus on the primary responsibilities and accountabilities of the RP and their role as quality management representative within the Supply Chain
    • Have a clear understanding of the role of the Competent Authority for medicinal products in the licensing of the wholesale dealing of medicines and as the competent authority in the enforcement of Good Distribution Practice (GDP) guidelines
    • Have an understanding of the relevant role of National Organisations that also regulate the Supply Chain of medicinal product control
    • Understand all aspects of the European Pharmaceutical directives and guidelines related to GDP for Medicinal Products and be aware of Good Manufacturing Practices (GMP) within the Supply Chain
    • Understand and recognise best practice in Good Distribution Practice (GDP) and why this is essential in maintaining the quality and the integrity of medicinal products throughout the supply chain
    • Appreciate how to apply and maintain the knowledge of how an effective quality compliance system that meets the requirements can be implemented maintained and improved
    • Be able to identify a medicinal product, the different legal categories, storage conditions and Marketing Authorisation (MA) types such that they can be appropriately handled, stored, managed and supplied. Understand the importance of applying due diligence in the discharge of his/her duties and of reporting to senior management, the competent authority and the MA holder any suspicious events of which he/she becomes aware, such as non-compliant products or the receipt or offer of medicinal products which are suspected of or identified as being falsified
    • Understand how to review the effectiveness of an organisation’s quality management system and implement effective corrective and preventive actions (CAPA) to address any deficiencies or non-conformance issue identified. These may include product recalls, disposal and physical segregation etc.

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Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Early-bird, Group booking, NHS and Seasonal discounts.

Meet the tutors

Jane Wright

Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.

Paul Palmer

Paul has over 30 years in the pharmaceutical industry and has been a Qualified Person and Responsible Person since 2006. He has an impressive resume, having worked for some of the largest pharmaceutical companies holding Head/Director of Quality, QP and RP roles on a permanent and contract basis. Since 2011, Paul has run is own pharmaceutical consultancy business providing; QP, RP, auditing, inspection preparation, regulatory compliance, QP mentoring and also GMP and GDP training services. These services have been delivered to pharmaceutical companies who's functions cover, clinical research, small and large molecule medicines manufacture and all aspects of the pharmaceutical supply chain.

Charlotte Abbott

Charlotte has many years experience as a RP / QA / Lead Auditor professional with international experience encompassing all aspects of the auditing process, including: inspection, assessment and assurance of GMP / GDP guidelines, managing internal audits and compliance reviews.

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