Responsible Person and GDP - Cogent Gold Standard Approved
: 25 Aug 2020 - 27 Aug 2020
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.
If your organisation already has or is applying for a Wholesale Dealers Authorisation (WDA) they must have a Responsible Person (RP) named on the license. The RP must ensure compliance with Good Distribution Practice (GDP) and fully understand the legal responsibilities of an organisation holding a (WDA) license. Thereby, ensuring all medicinal products are purchased and sold within the legal supply chain and receive the correct handling, transportation, storage, and distribution of medicinal products.
Another core requirement of GDP is to have a well-designed Quality Management System (QMS) with a focus on compliance and continual improvement. The RP is legally required to ensure the QMS is implemented by maintaining oversite of its routine operation. This area will be covered in detail as it has been highlighted by the medicines and healthcare products regulatory agency as the number one area deficiencies are found during inspections for several years.
This course has been designed for people who are seeking to be named as a Responsible Person on a WDA. However, the content is also relevant in the education of those who are involved in the procurement and sale of medicinal products, including WDA 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 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.