Responsible Person and Good Distribution Practice
16hrs instructor led, 5hrs self-paced
About This Course
Cogent Gold Standard Approved Training
Learn how to become a Responsible Person (RP), the duties and responsibilities of an RP and the future role of the RPi (Responsible Person (import)) post-Brexit.
Supported and recognized by the MHRA, NSF’s Responsible Person and Good Distribution Practice course meets the Cogent Gold Standard competencies for the role of the Responsible Person in Medicinal Products and the accompanying standard. After completion of our Gold Standard RP and Good Distribution Practice (GDP) training, you will receive a certificate from Cogent Skills featuring the MHRA logo.
This lively and interactive RP and GDP course is presented virtually through a combination of self-paced learning hosted on our learning management system and four half-day virtual classroom sessions. Full details will be sent to you by email following registration. Focusing on the key requirements for the distribution and storage of pharmaceutical products and materials, our training enables delegates to understand and effectively implement the principles of GDP at their facilities, as well as to carry out the role of the RP.
Why You Should Attend
This GDP and Responsible Person training course provides you with a thorough understanding of the regulatory requirements for operating within a storage and distribution center for materials or medicinal products in the pharmaceutical industry.
It will also give a practical understanding of the systems and processes required to be implemented to ensure that your operation is compliant and delivers product that is safe and efficacious in an efficient manner.
Interactive discussion groups provide a great opportunity to network with others in the same industry and learn from their experiences, and you will also practice applying knowledge through scenarios, quizzes and team works.
This course is suitable for all levels of people involved in the handling and storage of medicines and pharmaceutical materials, from those working for multi-national companies distributing product worldwide to small independent warehouses wholesaling medicines.
- Falsified medicines
- The EMA and EU Directives
- The MHRA and UK regulations
- Authorizations and GDP guidelines
- All elements of the quality management system, including qualification of customers and suppliers, transportation, quality agreements and outsourced activities
- How to become an RP, the duties and responsibilities of an RP and the future role of the RPi post-Brexit
Key Learning Objectives
By the end of this GDP and Responsible Person training course, you will:
- Have both the technical and behavioral skills required to be an RP
- Have knowledge of legislative requirements for the storage and distribution of excipients, active substances and medicinal products
- Know the fundamental elements of good distribution and storage practices
- Know practical examples and best practices of how to implement key systems
- Have a wider network of professionals working in distribution
Who Should Attend
- Trainee RPs
- RPs looking for a training refresher
- New warehouse supervisors and managers or personnel who are new to GDP operations
- Warehouse operatives, supervisors and managers who are new to the pharmaceutical industry
- Auditors who are expected to inspect storage facilities
- Personnel from new distribution operations
Samantha Clack has worked in the pharmaceutical industry for over 20 years, ten years as a Qualified Person. She is currently named on licenses as the Qualified Person and is also named and acts as an RP on wholesale distribution licenses. She has extensive hands-on knowledge of pharmaceutical manufacturing and distribution and has worked for large multi-national companies as well as smaller operations including virtual organizations.
Catherine Kay - Catherine has extensive pharmaceutical operations management, technical and QA experience spanning more than 23 years, gained working for a major international pharmaceutical organization, a start-up manufacturing organization and, most recently, a contract manufacturing organization in a corporate operations role.
About the Cogent Skills Gold Standard
Cogent Skills alongside the MHRA have developed a new Gold Standard role profile for a Responsible Person in Medicinal Products which in turn has led to a training standard that is recognized by the MHRA.
The Responsible Person Gold Standard sets an industry-agreed framework that identifies the skills required by a Responsible Person in four skills areas. This spread of skills ensures that the role includes not only the traditional qualifications and technical requirements but also the behavioral skills required to do the job to a high standard. These include business improvement, leadership and communication. The training standard shows what good training entails to meet the Gold Standard competencies which NSF’s GDP and RP training incorporates.
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