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, and the new requirements included in the MHRA Orange Guide.
Fully reviewing Good Distribution Practice (GDP) as
required by Licence Holders, it provides an nderstanding f the key GDP Quality Systems required to operate and ully meet regulatory requirements.
Fully reviewing Good Distribution Practice (GDP) as
required by Licence Holders, it provides an nderstanding f the key GDP Quality Systems required to operate and ully meet regulatory requirements.