Compliance and Validation Training Courses
Book onto this Course
Pharmaceutical Process Validation
This pharmaceutical validation training course provides attendees with a detailed appreciation of the full life cycle related to pharmaceutical and biopharmaceutical process validation. The course covers process validation for biopharmaceutical Active Pharmaceutical Ingredients (API’s) and a variety of pharmaceutical product formulations.
It 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 pilot / scale-up studies to production scale.
A detailed explanation of key regulations, guidelines and standards will be given, which includes the US FDA process validation guide, the EU process validation guide, EU Annex 15 and ICH Q8, Q9 and Q10. Validation documentation requirements and Continued Process Verification, together with critical supporting systems, e.g. quality risk management 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 30 Sep 2025, 18:30 onwards) that will include drinks and a sit-down dinner (fully complementary and everyone is welcome).
| September 2025 | ||||||
|---|---|---|---|---|---|---|
| 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 | ||||
| October 2025 | ||||||
|---|---|---|---|---|---|---|
| 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 | 31 | |
Tuesday, 30th September 2025 to Wednesday, 1st October 2025 (2 days)
Hotel Scandic Copenhagen, Denmark, Copenhagen, Denmark
09:00 - 17:00
£1,900 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
