What does it cover?
Offering a practical explanation of the guidelines for those implementing GDP the course covers an evaluation of the key roles and responsibilities of the Responsible Person (RP) & 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 current requirements included in the MHRA 2007 Orange Guide, and provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.
Offering a practical explanation of the guidelines for those implementing GDP the course covers an evaluation of the key roles and responsibilities of the Responsible Person (RP) & 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 current requirements included in the MHRA 2007 Orange Guide, and provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.
