An important part of every GMP- or GDP-regulated company

• Production and quality control
• Cleanroom operation and technology
• Hygiene concepts
• Documentation and data integrity

• Risk management and analysis
• Qualification and validation
• Method and process validation
• Cleaning validation

• Computer system validation
• GMP requirements for advanced therapy medicinal products (ATMPs)
• Requirements for investigational medicinal products
• Achievement of a manufacturing license according to §13 AMG

• Conditions of import according to § 72 ff AMG
• EN ISO 13485 & EN ISO 9001 compliance

• Responsibility under pharmaceutical law
• Supply chain security & counterfeit management
• Outsourced activities: storage and transport
• Qualification and mapping of storage facilities

• Validation of transports
• Deviations and recalls
• Export and import

If you need special GMP coaching to prepare for a professional position in the pharmaceutical, biotechnology, or ATMP manufacturing environment, we will train you individually and efficiently.

Our company-specific GMP coaching for newcomers enables them to quickly familiarize themselves with the relevant GMP topics. The scope of the training varies (1-3 days) depending on the desired GMP topics and depth of content. The training can be held on site, at Valicare in Frankfurt (up to 12 people), or virtually.