Participants will learn which important adjustments are necessary for the qualification and monitoring of cleanrooms, isolators and RABS systems in order to fulfil the new requirements. In addition, the requirements for cleaning and decontamination processes will be discussed and their evaluation and validation explained.
The seminar will also focus on the qualification of protective equipment and personnel in order to ensure compliance with the strict hygiene regulations. Participants will have the opportunity to deepen their knowledge of the latest filtration and aseptic filling requirements to ensure the sterility of their products at every stage of the production process. In addition, the speaker, Dr Gabriele Wanninger, former GMP, GDP and GCP inspector, will highlight the importance of aseptic process simulation (APS) and the validation of interventions in the manufacturing process.