Beschreibung
a-Learning: Deviations and CAPA
a-Learning-Basis-Modul
Deviations must be investigated!
Deviations must be reported and investigated. An assessment must be made as to whether the deviation has an impact on product quality. Corrective and preventive measures must be defined and implemented.
EU-GMP-GUIDE: Chapter 1
In this adaptive learning module, you will learn about the entire process of deviation investigation from notification to completion of the investigation according to the requirements of Chapter 1 of the EU GMP Guide. The differences between a deviation and a change are also addressed.
Content
- Fundamentals of deviations
- Quality defect management
- Documentation of deviations
- Evaluation of deviations
- Analysis of root causes
- Fundamentals corrections and CAPA
- Finalising the investigation
- Follow-Up
Outline
- You will learn why deviation management is necessary and how deviations are handled.
- You will receive an introduction to corrective and preventive actions (CAPA) and how they are determined
Audience
- Operational-level staff who need to report deviations
- Employees who need to process deviation reports
- Employees who determine CAPA
- Employees who want to get an overview of deviation management
Features
- Adaptive learning module
- Self-paced learning
- With certificate
Industries
- Pharmaceutical production
- Active substances
- Contract manufacturers
- Contract laboratories
- Sales & Distribution
- Logistics
- Subcontractors
a-Learning: Deviations and CAPA
Wissenswertes
Individual solution
This adaptive learning module can also be customized by our learning engineer team for your company with your internal information (e.g. contact details), content (e.g. organizational charts, schedules, forms, leaflets) and your corporate identity. Feel free to contact us!
License
Single license with a 60 day term.