20 – 21 September | Workshop | Reading, UK
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 new requirements included in the MHRA 2014 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 new Responsible Person Gold Standard, and is thus aligned with the underpinning training standard, of which RSSL was a contributor on the expert panel.
Offering a practical explanation of the guidelines for those implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products, the course is aimed at RP’s, Deputy RP’s or those planning to become an RP.
It would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service. It is designed for all those who need to understand the key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence.
Event venue: RSSL Reading Enterprise Centre, Reading