Pharmaceutical Training → GDP

TR108: Good Distribution Practice - Fundamentals and Inspections (Complete) (TR108)


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 to GDP video
  • 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
  • Module 8 - Common GDP Deficiencies
  • GDP 8 - Common GDP Deficiencies video tutorial
  • GDP 8 - Common GDP Deficiencies Assessment
  • Module 9 The Responsible Person
  • GDP 9 - The RP video tutorial
  • GDP 9 - The RP Assessment
  • Module 10 - Cold Chain
  • GDP 10 - Cold Chain video tutorial
  • GDP 10 = Cold Chain Assessment
  • Module 11 - EMP, CD & PI
  • GDP 11 - EMP, CD & PI video tutorial
  • GDP 11 - EMP, CD & PI Assessment
  • Module 12 - Deviations, Risk and Evaluations
  • GDP 12 - Deviations, Risk & Validation video tutorial
  • GDP 12 Deviations, Change and Risk Assessment
  • Module 13 - Guidelines for Efficient Inspections
  • GDP 13 - Guideline for Efficient Inspections video tutorial
  • GDP 13 - Guidelines for Efficient Inspections Assessment
  • Module 14 - Company Players
  • GDP 14 - Company Players video tutorial
  • GDP 14 - Company Players Assessment
Completion rules
  • All units must be completed
  • Leads to a certification with a duration: Forever