GMP and GDP Training

Regular GMP and GDP training is an important part of every GMP/GDP-regulated company

Only by corresponding annual training of all employees concerned and a subsequent learning success control, you will be able to meet the requirements of GMP or GDP.

Valicare GmbH supports you in this respect with on-line or in-house GMP basic training courses, which can last half a day or a whole day, depending on the desired intensity.

Valicare GmbH has extensive specialist knowledge to meet your individual needs. In order to optimize your training success, we can adapt the training material to your product range and integrate company-specific procedures and processes.

Our GMP training courses cover the following topics:

• GMP Basics
• Production and quality control
• Clean room operation and technology
• Hygiene Concepts
• Documentation and data integrity
• Risk management and analysis
• Qualification and validation
• Method and process validation
• Computer system validation
• GMP requirements for advanced therapy 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

GDP-relevant issues are in particular:

• 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

We are pleased to extend these title lists to include your specific subjects. The conclusion of each training course is an anonymous success control, based on which each training participant receives a certificate for his successful participation. The training documents are submitted in either electronic or paper form.

Please contact us if you require further information or a concrete offer.