Responsible Person Refresher

Course Overview

This one day refresher 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 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.

Suitability

The refresher course is aimed at RP’s and Deputy RP’s who have already undertaken initial RP training but who need to keep updated with current regulations and expectations of the competent authorities for Continuing Professional Development (CPD). Note, it is not a suitable alternative for those who have yet to undergo initial 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. Section 2.4 of Directive 2013/C 343/01 states that RPs should receive regular training to maintain their competence in GDP, this course is designed to meet this need.

Learning Outcomes

The refresher course is a highly interactive ‘hands on’ learning experience; breakout sessions will review the most recent examples of deficiencies found by regulators and how to address and improve compliance in these critical areas.

By the end of the course you will:

• Be familiar with the 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