Beschreibung
e-Learning: EU GMP Guideline Chapter 4 | Pharmaceutical Quality System
GMP-compliant documentation is an important element!
The GMP requirements for documentation can be found in Chapter 4 of the EU GMP Guide. The documentation consists of specification and recording documents and can be paper-based or electronic. What rules and specifications are there and how can they be implemented in practice?
Outline
In this module, you will learn about important GMP requirements for documentation and how to implement them in your daily working life.
You will refresh your GMP knowledge from training courses you have already completed.
Online short assessment and certificate
At the end of the module you may complete a short assessment. If you reach a passing score of at least 80%, you will receive your certificate via email.
Module language: English
Contents
- What is included in GMP documentation?
- How can documentation be available?
- Which documents are GMP-relevant?
- Aim and purpose of the documentation
- What is compliance?
- Specification: Documents
- Record-keeping documents
- The importance of the signature
- What is raw data?
- Data integrity at a glance
- GMP-compliant documentation systems
- Archiving
Audience
- Employees of quality units
- Employees in the management of GMP companies
- Employees of external companies who work for GMP areas
Features
- Interactive exercises
- Self-paced learning right at your workplace
- Glossary of helpful terms and explanations
- Suitable as initial training, but also as refresher training or follow-up training
- With certificate
Industries
- Pharmaceuticals
- Active Ingredients
- Contract manufacturers
- Sales
- Logistics
- Suppliers
Individual solution
This e-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 365 day term.
e-Learning: EU GMP Guideline Chapter 4 | Documentation
