Training OLD

Regular training is an important part of every company. Only by corresponding annual training of all employees concerned and a subsequent learning success control, you will be able to meet the requirements.
SERCOTECH 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 training courses cover the following topics:

  • GMP Basics
  • Clean room operation and technology
  • Hygiene Concepts
  • Production and quality control
  • Documentation and data integrity
  • Risk management and analysis
  • Qualification and validation
  • Method and process validation
  • Computer svstem validation
  • GMP requirements for advanced therapy products (ATMPs)
  • Requirements for investigational medicinal products
  • Achievement of a manufacturing license according to § 13 AMC
  • Conditions of import according to § 72 ff AMC
  • EN ISO 13485 & EN ISO 9001 compliance

DP-relevant issues are in darticular:

Responsibility under pharmaceutical law

Validation of transports

Deviations and recalls

Export and Import

Supply chain security & counterfeit management

Outsourced activities: Storage and transport

Qualification and mapping of storage facilities