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Responsible Person/

Deputy Responsible Person


Scope Suitability
This intensive 2-day course evaluates the key roles and Offering a practical explanation of the guidelines for
responsibilities of the Responsible Person (RP) and Deputy those implementing GDP, as well as those involved in
RP in relation to Directive 2001/83/EC, Directive 2004/27/ the management of quality systems for pharmaceutical
EC, EU Guidelines on Good Distribution of Medicinal products, the course is aimed at RP’s, Deputy RP’s or those
Products for Human Use 2013, and the new requirements planning to become an RP. It would also benefit quality
included in the MHRA 2014 Orange and Green Guides. managers, and personnel in regulatory, compliance,
Fully reviewing Good Distribution Practice (GDP) as distribution, warehousing, supply chain management
required by Licence Holders, it provides an understanding and customer service. It is designed for all those who need
of the key GDP Quality Systems required to operate and to understand the key GDP quality components necessary
fully meet regulatory requirements. to operate as a holder of an MHRA or EU Wholesale
Dealer’s Licence.
The course is designed to cover the key elements of the
new Responsible Person Gold Standard.

Tel: +44 (0)118 918 4076 E-mail: enquiries@rssl.com Bookings: bookings@rssl.com Web: www.rssl.com

RSSL Training
Reading Enterprise Centre, Earley Gate, Whiteknights Road, Reading, Berkshire, RG6 6BU
Responsible Person/
Deputy Responsible Person
Learning Outcomes
The course is a highly interactive ‘hands on’ learning • Be familiar with GDP guidelines as covered by EU
experience; detailed breakout sessions review actual Directives/Regulations and Guidelines (including the
sample deficiencies found by regulators and how to Orange and Green Guides).
address and improve compliance in these critical areas. • Understand how to establish and maintain bona fides
At the end of the course you will: for all your suppliers and customers, and the compliant
• Understand what your key responsibilities are as an management of supply chains
RP and or Quality Champion • Have detailed knowledge on the best in class standards
• Have a clear understanding of your key responsibilities of GDP and why is it so essential for patient safety
and accountabilities with a clear focus on the legal and • Appreciate the dangers and challenges posed by
compliance aspects falsified products
• Have a comprehensive understanding of the MHRA/EU
Regulator expectations and how to address and correct
actual deficiencies

Tel: +44 (0)118 918 4076 E-mail: enquiries@rssl.com Bookings: bookings@rssl.com Web: www.rssl.com

RSSL Training
Reading Enterprise Centre, Earley Gate, Whiteknights Road, Reading, Berkshire, RG6 6BU