Basics - GDP and FMD Course

Training Overview:
  • Overview of Regulations and Regulatory Requirements
  • Good Distribution Practice*
  • Falsified Medicines Directive
*GDP Chapters
  1. Quality Management
  2. Personnel
  3. Premises and Equipment
  4. Documentation
  5. Operations
  6. Complaints, Returns, Suspected Falsified Medicines, Recalls
  7. Outsourced Activities
  8. Self Inspections
  9. Transportation
  10. Brokers

 

08:30 - 09:00

Welcome, Introduction, Presentation of Speaker
09:00 - 09:15 EU & Global Regulations
Local Regulations
09:15 - 10:30 Chapter 1 Quality Management
Chapter 2 Personnel
Chapter 3 Premises and Equipment
10:30 - 10:45 Break
10:45 - 12:00 Chapter 4 Documentation
Chapter 5 Operations
Chapter 6 Complaints, Returns, Suspected Falsified Medicinal Products and Recalls
12:00 - 12:45 Chapter 7 Outsourced Activities
Chapter 8 Self-Inspections
12:45 - 13:30 Lunch
13:30 - 14:30 Chapter 9 Transportation
Chapter 10 Brokering
Discussion / Questions and Answers
14:30 - 14:45 Break
14:45 - 16:00 Falsified Medicines Directive
16:00 - 16:30 Discussion / Questions and Answers

 

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