Course Scope:
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/C 343/01 and the new requirements included in the MHRA 2014 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.
This course is designed to cover the key elements of the new Responsible Person Gold Standard, and is thus aligned with the Training Standard currently being developed, and to which RSSL is a contributor on the Expert Panel.
Overview:
Course Scope
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/C 343/01 and the new requirements included in the MHRA 2014 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.
This course is designed to cover the key elements of the new Responsible Person Gold Standard, and is thus aligned with the Training Standard currently being developed, and to which RSSL is a contributor on the Expert Panel.
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/C 343/01 and the new requirements included in the MHRA 2014 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.
This course is designed to cover the key elements of the new Responsible Person Gold Standard, and is thus aligned with the Training Standard currently being developed, and to which RSSL is a contributor on the Expert Panel.
Overview:
Course Scope
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/C 343/01 and the new requirements included in the MHRA 2014 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.
This course is designed to cover the key elements of the new Responsible Person Gold Standard, and is thus aligned with the Training Standard currently being developed, and to which RSSL is a contributor on the Expert Panel.
