Conference & Events
Event Details
Good Distribution Practice
This intensive 1-day 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 94/C 63/03 and the new requirements included in the MHRA 2007 Orange Guide. 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.
Date: 04 October 2012 09:00 - 17:00
Venue
RSSL Pharma Training
The Science & Technology Centre
Whiteknights Road
Reading
RG6 6BZ
United Kingdom
Find this location using Google Map
Useful link:
http://www.rssl.com/services/pharmaceuticalandhealthcar...
Organiser Information
Organiser(s): Rachel Horton
Contact for Event Information
Name : Mrs Rachel Horton
Address:
Reading Scientific Services Ltd
The Reading Science Centre
Whiteknights Campus
Reading
RG6 6LA
United Kingdom
Tel:
0118 9184024
Email:
rachel.horton@rssl.com
Additional Information
Speaker Information:
This intensive 1-day 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 94/C 63/03 and the new requirements included in the MHRA 2007 Orange Guide. 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.
Booking form or other file(s):
Pharma Training Calendar 2012 Oct 2011.pdf
Useful link:
http://www.rssl.com/services/pharmaceuticalandhealthcar...
Other information:
Suitability:
The course is aimed at any company that has, or is,
considering obtaining an MHRA wholesale dealer’s
licence/EU licence, wholesalers/distributors, manufacturers, pharmaceutical suppliers, service/transport providers and partners.
Responsible Persons’s (RP), deputy RP’s, quality managers, and regulatory/compliance personnel will all benefit from this course.
Additionally it is also recommended for those in logistics, supply chain, warehousing, transport and distribution, customer services and purchasing.
It may be modified to run in-house within client
companies.
Learning Outcomes:
The course is a highly interactive ‘hands on’ learning
experience, by the end of which you will:
• 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
