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 94/C 63/03, and the new requirements included in the MHRA 2007 Orange Guide. 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. Importantly, it also covers the knowledge and competency
requirements laid out in the Study Guide for the new RP qualification, being introduced in 2011.
fully meet regulatory requirements. Importantly, it also covers the knowledge and competency
requirements laid out in the Study Guide for the new RP qualification, being introduced in 2011.
