Course Scope
The course is aimed at any company that has, or is, considering obtaining 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.Responsible Persons’s (RP), deputy RP’s, quality managers, auditors, 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.
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 new requirements included in the MHRA 2014 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.
Learning Outcomes
The course is a highly interactive ‘hands on’ learning experience, by the end of which you will:
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Understand what GDP is and why is it so essential for patient safety
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Be familiar with GDP as covered by EU Directives/Regulations and Guidelines (including the ‘Orange Guide’)
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Understand the MHRA perspective on the guidelines, and their expectations with regard to GDP in practice
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Have an insight in to current MHRA ‘Hot Topics’ in GDP
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Appreciate the dangers and challenges posed by counterfeit products
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Understand your GDP responsibility from product sourcing through to final customer delivery
