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TMS RUS
TMS RUS is a cooperation partner of
TÜV SÜD in EEU countries
 

GDP requirements. Practice of implementation

Training on the requirements and implementation practice Good Distribution Practice was developed by our company on the basis of many years of experience in building the correct processes of storage, transportation and distribution.

The training is built on the basis of the requirements EU Guideline Good Distribution Practice for Medicinal Products for Human Use (2013 / C 68/01), and practices for improving processes based on the requirements of ISO 9001 are additionally considered. The training is intended for a wide range of participants who develop, implement improve distribution processes.

The training will be considered:

  • Objectives and planned results of storage, transportation and distribution processes. Consumer expectations. KPI processes. Process risks, risk management.
  • Requirements for the infrastructure of distribution processes: buildings, vehicles, equipment, computerized systems.
  • Requirements for the main processes (acceptance, storage, shipment, transportation), their stability, traceability and achievement of results. Support Process Requirements.
  • Quality assurance activities: staff training, work with documentation, management of claims, reviews, returns. Self-inspection.
  • Non-Conformity Management.

As a result of the training participants will receive not only knowledge about the requirements and best practices of the implementation of distribution processes, but also within the framework of practical tasks will develop projects decisions on process indicators, their implementation algorithms, projects forms of documents for traceability. One of the important learning results we consider is the achievement by participants of the understanding of the process risks and customer’s requirements.

At the end of the training, a final document on advanced training is issued.

To obtain a detailed training program and the trainer CV please contact us at: info@tms-cs.ru