Pharmaceutical Training → GDP

TR109: Good Distribution Practice - Fundamentals and Inspections (Foundation) (TR109)


Description
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. Since the revised EU GDP Guidelines were implemented in 2013, new challenges have arisen for the Pharmaceutical Wholesaling environment.

about the course

The course 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. It will also focus on advanced aspects of GDP, including focus on the areas of responsibility for applicant and existing Responsible Persons
Content
  • Module 1 - Introduction & Welcome
  • GDP 1 - Introduction and Welcome
  • Module 2 - GDP Training
  • GDP 2 - Training video tutorial
  • GDP 2 - Training Assessment
  • Module 3 - Establishing Bona Fides
  • GDP 3 - Establishing Bona Fides video tutorial
  • GDP 3 - Establishing Bona Fides Assessment
  • Module 4 - Falsified Medicinal Products
  • GDP 4 - Falsified Medicinal Products video tutorial
  • GDP 4 - Falsified Medical Products Assessment
  • Module 5 - Virtual Wholesaling
  • GDP 5 - Virtual Wholesaling video tutorial
  • GDP 5 - Virtual Wholesaling Assessment
  • Module 6 - GDP Guidelines
  • GDP 6 - GDP Guidelines video tutorial
  • GDP 6 - GDP Guidelines Assessment
  • Module 7 - Contractual Agreements
  • GDP 7 - Contractual Agreements video tutorial
  • GDP 7 - Contractual Agreements Assessment
Completion rules
  • All units must be completed
  • Leads to a certification with a duration: Forever