GDP

Good Distribution Practice Training

This course is prepared for companies and individuals that need to get familiar with the fundamentals of Good Distribution Practice. It covers the latest GDP guidelines, principles and requirements.

€59 Enroll

Why enroll in this course?

Course Syllabus

  • What is GDP
  • Why is GDP Important?
  • Regulation of the Distribution of Pharmaceutical Products
  • To be considered
  • General GDP Principles
  • Principle
  • Pharmaceutical Quality System - Overview
  • PQS Implementation
  • KNOWLEDGE CHECKPOINT
  • Important Details about PQS
  • Management Review
  • Self - Inspections
  • Quality Risk Management
  • Overview of a typical quality risk management process
  • Principle
  • Key Personnel
  • Qualified Person
  • QP - Knowledge and Experience Requirements
  • QP - Duties
  • Staff Training in Terms of GDP
  • Personnel Hygiene
  • Principle
  • Premises
  • Storage Area
  • Temperature and Environment Control
  • Vehicles and Equipment
  • Computerized Systems
  • Shipment Containers and Container Labelling
  • Principle
  • Generation and Control of Documentation
  • How to make a correction
  • KNOWLEDGE CHECKPOINT
  • Good Documentation Practices
  • Records
  • Retention of Documents
  • Traceability of Pharmaceutical Products
  • Principle
  • Complaints
  • Returns
  • Falsified Medicinal Products
  • Product Recalls
  • KNOWLEDGE CHECKPOINT
  • Classification of Defects
    • Class I Defects
    • Class II Defects
    • Class III Defects
  • Rapid Alert Notification of a Quality Defect
  • Rapid Alert Notification Form
  • Destruction of Obsolete Goods

Ready to get started?

€59 Enroll