Audience

Aimed at those with an MHRA/EU Wholesale Distribution Authorisation, wholesalers/distributors, manufacturers, pharmaceutical suppliers, brokers, service/transport providers and partners who carry out any GDP activities on behalf of licence holders.

Duration

1 day

Objectives

By the end of the course you will be able to:
• Understand what GDP is and why is it so essential for patient safety
• Be familiar with GDP as covered by EU Directives/Regulations and Guidelines (including the ‘Orange Guide’)
• Understand the MHRA perspective on the guidelines, and their expectations with regard to GDP in practice
• Have an insight in to current MHRA ‘Hot Topics’ in GDP
• Appreciate the dangers and challenges posed by counterfeit products
• Understand your GDP responsibility from product sourcing through to final customer delivery

Content

This intensive course is intended to evaluate Good Distribution Practice (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 2003/C343/01 and the requirements included in the MHRA Orange/Green Guides.

It offers a practical explanation of the guidelines for those who are active in the field of setting up and implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products.

It reviews GMP/GDP supply chain integrity and examines the risk of counterfeit pharmaceutical products, a growing concern today. The course also reviews sample deficiencies found by regulators and how to improve compliance in these critical areas.

Cost

Non-Member - £695 + VAT
One Nucleus Member* – £556 + VAT 

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com