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.
Please note: This course is not suitable for those who have no previous knowledge of GDP. A prerequisite for attending this course is a good understanding of GDP, either gained in the workplace or by attending a GDP training course.
The course offers 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.
Course cost: £1390 (+VAT)
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