Good manufacturing practices requirements and application

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Objectives

  • Knowing the scope of application of GMPs
  • Identifying key requirements
  • Knowing how to apply them and understanding the importance of your daily involvement

Audience concerned

Manufacturers/subcontractors in the healthcare sector:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, Purchasing, etc.

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Chapter 1 – Pharmaceutical quality system
  3. Chapter 2 – Personnel
  4. Chapter 3 – Premises
  5. Chapter 4 – Documentation
  6. Chapter 5 – Production
  7. Chapter 6 – Quality control
  8. Chapter 7 – Outsourced activities
  9. Chapter 8 – Complaints, quality faults and recalls of medicines
  10. Chapter 9 – Self-inspection
  11. Quality risk management (ICH Q9)
  12. Annex 15: Qualification and Validation
  13. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CABPF

E-learning available on request

Informations and registration : academy@caduceum.co.uk