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Cleaning and Cleaning Validation (3 Day)

This course covers key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable effective, ‘easy’ cleaning and provides a detailed understanding of the approach to validating cleaning processes. This includes understanding the material carry-over (contamination) mechanisms involved, which are pivotal to setting meaningful limits for maximum allowable carry-over [MACO] limits. The course also covers applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO (for a wide range of residue types), based on health based exposure limits (HBELS) for highly hazardous and non-highly hazardous materials; methods for sampling/detecting/quantifying residues; and clean/dirty hold times. A matrix approach to cleaning validation for multi-product, non-dedicated equipment is also covered. Other areas covered are cleaning process monitoring/review, maintaining the validated state and dealing with common examples of cleaning issues that may arise during routine operation.


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September 2020
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Tuesday, 8th September 2020 to Thursday, 10th September 2020 (3 days)

We use GoToWebinar® 'standard webinars' for our online courses.
Please check your system compatibility before booking

08:00 - 16:00 (London/Dublin)

09:00 - 17:00 (Amsterdam/Berlin)

£1,495 per delegate

NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK and/or delegates are UK based