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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Copenhagen Marriott Hotel, Copenhagen, Denmark

www.marriott.com/hotels/hotel-photos/cphdk-copenhagen-marriott-hotel/

Copenhagen Marriott Hotel
Kalvebod Brygge 5
Copenhagen
1560
Denmark

+45-88-33-99-00

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Wednesday, 18^th September 2019 to Friday, 20^th September 2019 (3 days)

Copenhagen Marriott Hotel, Copenhagen, Denmark

09:00 - 17:00

£1,995 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