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:
The course is a highly interactive ‘hands on’ learning experience; detailed breakout sessions review actual sample deficiencies found by regulators and how to address and improve compliance in these critical areas.
At the end of the course you will:
•Understand what your key responsibilities are as an RP and or Quality Champion
•Have a clear understanding of your key responsibilities and accountabilities with a clear focus on the legal and compliance aspects
•Have a comprehensive understanding of the MHRA/EU Regulator expectations and how to address and correct actual deficiencies
•Be familiar with new 2013 GDP guidelines as covered by EU directives/regulations and guidelines (including the Orange and Green Guides)
•Understand how to establish and maintain bona fides for all your suppliers and customers, and the compliant management of supply chains
•Have detailed knowledge on the best in class standards of GDP and why is it so essential for patient safety
•Appreciate the dangers and challenges posed by falsified products
Who should attend:
Offering a practical explanation of the guidelines for those implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products, the course is aimed at RPs, Deputy RPs or those planning to become an RP. It would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service. It is designed for all those who need to understand the key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence.
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:
The course is a highly interactive ‘hands on’ learning experience; detailed breakout sessions review actual sample deficiencies found by regulators and how to address and improve compliance in these critical areas.
At the end of the course you will:
•Understand what your key responsibilities are as an RP and or Quality Champion
•Have a clear understanding of your key responsibilities and accountabilities with a clear focus on the legal and compliance aspects
•Have a comprehensive understanding of the MHRA/EU Regulator expectations and how to address and correct actual deficiencies
•Be familiar with new 2013 GDP guidelines as covered by EU directives/regulations and guidelines (including the Orange and Green Guides)
•Understand how to establish and maintain bona fides for all your suppliers and customers, and the compliant management of supply chains
•Have detailed knowledge on the best in class standards of GDP and why is it so essential for patient safety
•Appreciate the dangers and challenges posed by falsified products
Who should attend:
Offering a practical explanation of the guidelines for those implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products, the course is aimed at RPs, Deputy RPs or those planning to become an RP. It would also benefit quality managers, and personnel in regulatory, compliance, distribution, warehousing, supply chain management and customer service. It is designed for all those who need to understand the key GDP quality components necessary to operate as a holder of an MHRA or EU Wholesale Dealer’s Licence.
