This pharmaceutical validation training course provides attendees with an in-depth appreciation of project life-cycle activities associated with equipment system qualification. These activities range from early project planning through to design review and qualification of critical aspects / components of manufacturing systems.

A pivotal theme of the course is a risk-based approach to the qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500-20. As a result, System level Impact Assessments (System Classification), Component Criticality Assessments and the process of identifying critical aspects of manufacturing systems (System Risk Assessment).

With an ever increasing regulatory expectation and requirement that the level of system / function testing is based on risk to product quality / patient safety and system complexity / novelty, a typical process used to achieve this goal is included in the course (Quality Risk Assessment). Also included, is how the integration of qualification with commissioning can minimise duplication of effort and maximise the use of supplier's documentation.

Up-to-date information on current applicable regulatory and international standards / guidelines will be provided and 'real-life' examples will be used throughout the course.

The course will be presented by individuals who have extensive and recent ‘hands-on’ knowledge and experience of the subject.

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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