Compliance and Validation Training Courses
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Pharmaceutical Process Validation
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).
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Tuesday, 4th March 2025 to Thursday, 6th March 2025 (3 days)
Hotel Scandic Copenhagen, Denmark, Copenhagen, Denmark
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
