Compliance and Validation Training Courses
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Cleaning & Cleaning Validation
This course provides attendees with an in-depth appreciation of key design features of pharmaceutical and biopharmaceutical manufacturing equipment/systems to enable ‘easy’, effective cleaning (usually a far greater challenge than the validation). It also provides a detailed understanding of the approach to validating cleaning processes. This includes the fundamental understanding of material carryover (contamination) mechanisms and how this is pivotal to setting appropriate limits for acceptable levels of carryover (maximum allowable carryover [MACO] limits) from one product to another. The course also covers areas such as applicable regulatory rules & guidelines; demonstration of spray device coverage; methods for calculating MACO for large/small molecule compounds & cleaning agents); methods for sampling/detecting/quantifying residues (key considerations); inclusion of clean/dirty hold times in the validation study; the use of a matrix approach to multi-product non-dedicated equipment; cleaning process monitoring/review and maintaining the validated state. To help consolidate learning, presentations will be supplemented by case studies and workshops.
Attendees will be provided with a 3-slide per page printed binder upon arrival on Day 1 and PDF versions of the slides will be sent out by email to each delegate after the course.
Day-time meals and refreshments are included in the overall package. There will be an informal social gathering of attendees and presenters on the evening of Day 1 (Tuesday 25 Mar 2025, 18:30 onwards) that will include drinks and a sit-down dinner (fully complementary and everyone is welcome).
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Tuesday, 25th March 2025 to Thursday, 27th March 2025 (3 days)
Radisson Blu Royal Hotel, Dublin, Dublin 8, Ireland
09:00 - 17:00
£2,500 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
