Course Scope
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 2013/C 343/01 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.
Overview:
The course is a highly interactive 'hands-on' learning experience, at the end of which you will:
鈥nderstand what GDP is and why is it so essential for patient safety
鈥e familiar with GDP as covered by EU Directives/ Regulations and Guidelines (including the Orange and Green Guide)
鈥nderstand the MHRA perspective on the guidelines, and their expectations with regard to GDP in practice
鈥ave an insight into current MHRA 'Hot Topics' in GDP
鈥ppreciate the dangers and challenges posed by counterfeit products
鈥nderstand your GDP responsibility from product sourcing through to final customer delivery
Who should attend:
The course is aimed at any company that has, or is considering obtaining, an MHRA wholesale dealer鈥檚 licence/EU licence or Wholesale Distribution Authorisation (WDA); pharmaceutical suppliers and brokers; service/transport providers; and partners who carry out any GDP activities on behalf of licence holders.
Responsible Persons (RPs), deputy RPs, quality managers, auditors and regulatory/compliance personnel will all benefit from this course, and it is also recommended for those in logistics, supply chain, warehousing, transport and distribution, customer services and purchasing. The course can be modified to run in-house within client companies.
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 2013/C 343/01 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.
Overview:
The course is a highly interactive 'hands-on' learning experience, at the end of which you will:
鈥nderstand what GDP is and why is it so essential for patient safety
鈥e familiar with GDP as covered by EU Directives/ Regulations and Guidelines (including the Orange and Green Guide)
鈥nderstand the MHRA perspective on the guidelines, and their expectations with regard to GDP in practice
鈥ave an insight into current MHRA 'Hot Topics' in GDP
鈥ppreciate the dangers and challenges posed by counterfeit products
鈥nderstand your GDP responsibility from product sourcing through to final customer delivery
Who should attend:
The course is aimed at any company that has, or is considering obtaining, an MHRA wholesale dealer鈥檚 licence/EU licence or Wholesale Distribution Authorisation (WDA); pharmaceutical suppliers and brokers; service/transport providers; and partners who carry out any GDP activities on behalf of licence holders.
Responsible Persons (RPs), deputy RPs, quality managers, auditors and regulatory/compliance personnel will all benefit from this course, and it is also recommended for those in logistics, supply chain, warehousing, transport and distribution, customer services and purchasing. The course can be modified to run in-house within client companies.
