Course Scope;
This one day course offers a practical evaluation of the key roles and responsibilities of the Responsible Person (RP) and Deputy RP in the light of the extensive requirements included in the MHRA 2014 Orange/Green Guides in relation to current Good Distribution Practice (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC and the EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C 343/01. In particular it examines the implications of the changes.
Overview:
The course is a highly interactive ‘hands on’ learning experience; breakout sessions will review the most recent example deficiencies found by regulators and how to address and improve compliance in these critical areas.
At the end of the course you will:
•Be familiar with new 2013 GDP requirements as covered by EU directives/regulations and guidelines (including the ‘Orange Guide’)
•Understand the full breadth of your responsibilities and accountabilities as an RP and or Quality Champion, with a clear focus on the new legal and compliance aspects
•Have a comprehensive understanding of current MHRA/EU Regulator expectations and how to address and correct actual deficiencies
Who should attend:
The course is aimed at RP’s and Deputy RP’s who have not undertaken training since the new GDP requirements came in to force. It primarily focuses on the changes and the implications of these, it is not a suitable alternative for those who have yet to undergo any formal RP training. This ‘update’ course would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service who need to appreciate the implications of the changes. It is designed for all those who need to understand the revised key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence. For individuals who have no formal RP training we offer a two day RP course, which although covering the new requirements, covers much more by way of foundation learning.
This one day course offers a practical evaluation of the key roles and responsibilities of the Responsible Person (RP) and Deputy RP in the light of the extensive requirements included in the MHRA 2014 Orange/Green Guides in relation to current Good Distribution Practice (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC and the EU Guidelines on Good Distribution of Medicinal Products for Human Use 2013/C 343/01. In particular it examines the implications of the changes.
Overview:
The course is a highly interactive ‘hands on’ learning experience; breakout sessions will review the most recent example deficiencies found by regulators and how to address and improve compliance in these critical areas.
At the end of the course you will:
•Be familiar with new 2013 GDP requirements as covered by EU directives/regulations and guidelines (including the ‘Orange Guide’)
•Understand the full breadth of your responsibilities and accountabilities as an RP and or Quality Champion, with a clear focus on the new legal and compliance aspects
•Have a comprehensive understanding of current MHRA/EU Regulator expectations and how to address and correct actual deficiencies
Who should attend:
The course is aimed at RP’s and Deputy RP’s who have not undertaken training since the new GDP requirements came in to force. It primarily focuses on the changes and the implications of these, it is not a suitable alternative for those who have yet to undergo any formal RP training. This ‘update’ course would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service who need to appreciate the implications of the changes. It is designed for all those who need to understand the revised key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence. For individuals who have no formal RP training we offer a two day RP course, which although covering the new requirements, covers much more by way of foundation learning.
