Compliance and Validation Training Courses

DUBLIN 8 Equipment design for cleaning, effective cleaning, material carryover mechanisms and safe limits · 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).

COPENHAGEN 3-day course covering the validation of pharmaceutical and biopharmaceutical manufacturing processes · This pharmaceutical validation training course provides attendees with a detailed appreciation of the full life cycle related to pharmaceutical and bio-pharmaceutical process validation. The course covers process validation for pharmaceutical and bio-pharmaceutical Active Pharmaceutical Ingredients (API’s), a variety of pharmaceutical product formulations and primary/secondary packing. The course includes areas such as: the concept of Operating Space, Design Space and Knowledge Space and how this relates to real life; typical process design considerations; the importance of correctly identifying critical quality attributes and the control parameters that influence / affect them (using risk assessment tools to help); quality by design and design of experiments; equipment / process control philosophy and maintaining process development traceability from laboratory through to pilot / scale-up studies and eventual production scale. A typical approach to the validation of packing operations (covers different types of primary packaging) is included, together with an overview of key regulations, guidelines and standards, including the FDA process validation guide and ICH Q8. Validation documentation requirements, sampling requirements, acceptable quality levels, management of deviations and Continued Process Verification, together with critical GMP supporting systems are also covered by this course. 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 4 Mar 2025, 18:30 onwards) that will include drinks and a sit-down dinner (fully complementary and everyone is welcome).