Dates - 8th - 9th September 2010, 2nd - 3rd November 2010
Price - £1160 + VAT
Scope
This intensive 2-day course evaluates the key roles and responsibilities of the Responsible Person & Deputy RP (RP) in relation to 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.
Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.
Suitability
Offering a practical explanation of the guidelines for those implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products, the course is aimed at:
- Responsible Persons, Deputy Responsible Persons or individuals who are planning to become an RP
- Quality Managers, Regulatory/Compliance, Distribution/Warehousing and/or Supply Chain Management or Customer Service Purchasing personnel who:
need to understand more about the key GDP quality components necessary to operate under a wholesale or manufacturing licence as a MHRA Wholesale Dealer’s Licence/EU Licence holder
or
are involved in supplier and customer selection and approval
Outside of manufacturing and distribution, it is equally suitable for key personnel within the Wholesale and Brokerage sectors, and Transport Providers.
It may be modified to run in-house within client companies.
Knowledge
The course is a highly interactive 'hands on' learning experience; detailed breakout sessions will take place each day reviewing actual sample deficiencies found by regulators and how to address and improve compliance in these critical areas. By the end of the course you will:
- Understand what your key responsibilities are as an RP and or Quality Champion.
- Have prepared a Role Profile/Job Description for your key responsibilities and accountabilities with clarity on your legal and compliance responsibilities.
- Have a comprehensive understanding of the current expectation of regulators and reviewed recent regulatory deficiencies
- Have learnt how to address and correct actual regulatory deficiencies.
- Be familiar with GDP as covered by EU Directives/Regulations & Guidelines (including the ‘Orange Guide’)
- Understand how to establish and maintain bona fides for all your suppliers and customers, and the compliant management of supply chains.
- Have detailed knowledge on the best in class standards of GDP is and why is it so essential for patient safety
- Understand the MHRA/EU Regulator perspective and their expectations with regard to GDP in practice on the ground.
- Appreciate the dangers and challenges posed by counterfeit products
- Understand your GDP responsibility from product sourcing through to final customer delivery
To book a training course, please download the booking form,
complete and email to bookings@rssl.com