Aimed at RP’s, Deputy RP’s or those planning to become an RP. Please note: this course is not suitable for those who have no previous knowledge of GDP.
Duration
2 days
Objectives
By the end of the course you will:
Understand what your key responsibilities are as an RP and or Quality Champion
Have a clear understanding of your key responsibilities and accountabilities with a clear focus on the legal and compliance aspects
Have a comprehensive understanding of the MHRA/EU Regulator expectations and how to address and correct actual deficiencies
Be familiar with latest GDP guidelines as covered by EU directives/regulations and guidelines (including the Green and Orange Guide)
Understand how to establish and maintain bona fides for all your suppliers and customers, and the compliant management of supply chains
Have detailed knowledge on the best in class standards of GDP and why is it so essential for patient safety
Appreciate the dangers and challenges posed by falsified products
Content
This intensive 2-day course evaluates the key roles and responsibilities of the Responsible Person (RP) and Deputy RP in relation to Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C343/01 and the latest requirements included in the MHRA Orange/Green Guides.
Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.
The course is designed to cover the key elements of the Responsible Person Gold Standard, and is thus aligned with the underpinning training standard, of which RSSL was a contributor on the expert panel.
