Serena Stiedl, Advisory Expert at Particle Measuring Systems, discusses Validation and Qualification of Environmental Monitoring equipment in Pharmaceutical Manufacturing with Blu Buquoy.
Listen to this podcast to learn about:
* What is cleanroom validation and qualification, with examples?
* What is needed to perform these activities in a limited timeframe?
* Annex 1 revision impact on lyophilization and smoke studies.
* How to qualify an online viable particle counter.
* How often should requalification be performed?