Basic GDP and FMD Course - An Introduction to Good Distribution Practice and Falsified Medicines Directive

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

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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