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.
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