good distribution practice
fundamentals and inspections (online 2 x half days)
Good Distribution Practice (GDP) is the standard set down in European Directives to which wholesalers of medicinal products must comply. GDP forms the basis of the Quality Management System operated by wholesalers. With the recently published amendment to Directive 2001/83/EC and the new EU Guidelines to GDP there are new challenges to all levels of wholesaling operations.
The course will be delivered in conjunction with The Compliance Group, over two days.
The Day One session will include the basic requirements for GDP, focusing on the new legislation, how to apply for and maintain a wholesaler’s authorisation and the minimum requirements required. There will be a site visit in the afternoon.
The Day Two session will focus on advanced aspects of GDP, including focus on the areas of responsibility for applicant and existing Responsible Persons. There will be a site visit in the afternoon.
event date: tbc, duration 2 x 4.5 hours
individual price: €500 per person for one day, €800 per person for two days.
location: online via Google Meet
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