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Description
Table of Contents
Intensive webinar: blood and blood preparations
Basis Webinar, 04.12.2026
Start: 9:00 a.m.
End: ca. 16:30 UHR
Subject: GMP
Target group: beginner
GMP special
You will find out the overview of the currently relevant drug law and GMP requirements for blood products. You recognize the best practices when implementing the requirements for blood and blood products. There are special requirements for blood preparations both in the AMG and in the EU controls. However, there are also relatively large number of requirements. In this webinar you will receive the overview of the GMP requirements in Germany and the EU.
Contents
- Regulations in general: AMG, AMWHV, EU GMP guidelines, EU regulations and guidelines, guidelines
- Special requirements blood and tissue
- Background to GMP: Why GMP? History and current status
- Quality and quality management system
- Personnel: Responsible persons (QP, VP, LH, LQK, LQS), delimitation of responsibilities, responsibilities of the management
- Training, success control
- Documentation: Document management system, changes in the documentation, SOPS hygiene
- Deviations and changes
- Supplier qualification
- Self -inspections
- Qualification, validation
- Quality Risk Management
Goals
- Special requirements from the regulations
- The responsibility of the officials
- Delegation options
- dealing with deviations, capas and changes
Target group
- Funeral sponsor (expert person, responsible persons, LH, LQK, LQS)
- Employees of blood donation facilities, blood and plasmal suppliers
- Pharmaceutical companies in particular from the areas of manufacture, quality management and quality control.
- Employees quality assurance, quality management
Special features
- MIT GMP-Inspector
- Workshops for inspections: Findings and frequent vulnerabilities
The industry
- Facilities for blood and blood preparations
- Manufacturer and pharmaceutical entrepreneur
- Wage manufacturers and wage laboratories
- Active substance manufacturer
Proof of training
- After passing success, you will receive a certificate
- If you have failed or not carried out, you will automatically receive a certificate of participation
Intensive care webinar: blood and blood preparations (04.12.2026)
Speaker
Xenia Dimont, government of Upper Bavaria
