Compliance and Validation Training Courses
Book onto this Course (Online)
Cleaning & 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.
PLEASE NOTE: There may be an option of booking this course as a 4 day course, which includes a practical day at a vessel cleaning development facility (Tuesday 17 Sep 2019). We are not certain of the availability of the facility at this time, but anyone booking this 3-day option will get first refusal on the 4-day course, if the facility is available. 4-day option costs £2395.
Brochure available soon.
September 2019 | ||||||
---|---|---|---|---|---|---|
Su | Mo | Tu | We | Th | Fr | Sa |
1 | 2 | 3 | 4 | 5 | 6 | 7 |
8 | 9 | 10 | 11 | 12 | 13 | 14 |
15 | 16 | 17 | 18 | 19 | 20 | 21 |
22 | 23 | 24 | 25 | 26 | 27 | 28 |
29 | 30 |
Wednesday, 18th September 2019 to Friday, 20th 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