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 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 receive PDF file versions of all the presentations by email. Presentations for each day will be sent out the day before the start of the respective day of the course.

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