Pharmaceutical Process Validation (2-Day)
This online 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 secondary packing operations is included, together with an overview of key regulations, guidelines and standards, including the latest 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.
PLEASE NOTE: There is an option of booking this course as a 4 day course, which includes the following Equipment System Qualification course. Please refer back to course schedule - click on 'Back to More Courses...', below:
Tuesday, 13th October 2020 to Wednesday, 14th October 2020 (2 days)
We use GoToWebinar® 'standard webinars' for our online courses.
Please check your system compatibility before booking
08:00 - 16:00 (London/Dublin)
09:00 - 17:00 (Amsterdam/Berlin)
£1,120 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