Beschreibung
e-Learning: Documentation
e-Learning-special-module
GMP-compliant documentation is an important element!
The GMP requirements for documentation can be found in Chapter 4 of the EU GMP Guideline. The documentation consists of standard and recording documents and can be paper-based or electronic. What rules and guidelines are there and how can they be implemented in practice?
Content
- What is part of the GMP documentation?
- How can documentation be done?
- Which documents are GMP-relevant?
- Purpose of the documentation
- What is Compliance?
- Specification documents
- Recording documents
- The meaning of the signature
- What are raw data?
- GMP-compliant documentation systems
- Archiving
- Final assessment (optional)
Objectives
- In this module, you will learn about important GMP documentation requirements and how to implement them in practice.
- You will refresh your GMP knowledge from previously completed training courses.
- You will complete a final assessment to obtain a certificate.
Target groups
- Employees of quality units
- Employees who create, manage or apply SOPs
- Employees of external companies working in GMP areas
- Suitable as initial training, refresher training or retraining
Special features
- Interactive exercises
- Learn at your own pace
- From your workplace
- Glossary with helpful terms and explanations
- With certificate
Industry sectors
- Medicinal products
- Active ingredients
- Contract manufacturers
- Contract laboratories
- Sales & Distribution
- Logistics
- Suppliers
e-Learning: Documentation
Teilnahmegebühr
Vollversion mit Erfolgskontrolle und Zertifikat 219,95 € inkl. Mehrwertsteuer
Entspricht einer Einzellizenz mit einer Laufzeit von einem Jahr. Bei mehreren Nutzern sind individuelle Preisabsprachen möglich. Bitte sprechen Sie uns an. Wir stehen Ihnen für weitere Fragen zur Verfügung.
