Compliance and Validation Training Courses
Cleaning and Cleaning Validation (Including a Practical Day)
This course provides delegates 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
This course incorporates a Practical Day, which will be held at Alfa Laval’s Application & Innovation Centre, Kolding, Denmark (transport included) and will help strengthen learning from the first 2-days of the of hotel based training. During this day, delegates will be presented with information on the dynamics of fluid flow in cleaning applications. There will be demonstrations of how coverage can be verified (using Riboflavin). Further demonstrations will show how different types of spray devices perform when cleaning a challenging residue. Swabbing and TOC analysis will also be covered.
Delegates 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, together with a course dinner, held on the evening of Day 1 (Tuesday 23 Apr 2024), are included in the overall package.
