The Responsible Person for Good Distribution Practice (GDP)

The Responsible Person for Good Distribution Practice (GDP)

The EU GDP Guidelines In 2013 the ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ were published. require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.

Brand

Brand

GXPWAY

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Training Description

The Responsible Person for Good Distribution Practice (GDP) for pharmaceutical professionals

 

Overview
The EU GDP Guidelines In 2013 the ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ were published. require that wholesale distributors have to appoint a Responsible Person (RP) for GDP. There has been a lot of discussion about the duties of the RP. Therefore. In this course, the role and responsibilities of the Responsible Person for GDP will be highlighted and discussed.

 

Course Outlines
• The EU GDP Guidelines
• Roles and Responsibilities of the Responsible Person
• What to learn from GMP/GDP Inspections and Audits
• GDP Audit Onsite and Remote
• Management of Export and Import
• Storage and Transport
• Shipment handing and management
• Warehouse Management
• Temperature Controlled Distribution
• Review and approval of Quality Agreement
• Management of Outsourcing activities


Who Should Attend

The Training Course is designed for new Responsible Persons RPs, prospective Responsible Persons RPs, experienced Responsible Persons RPs and other quality management, logistics and supply chain personnel wholesalers, distributors and service providers involved in distribution of medicinal products for human use.