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. The current course covers the new revised Guidelines, 2013/C 68/01 published on the 8th March 2013, and that are to be implemented within 6 months, by September 2013.
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.
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.
