Pharmaceutical Equipment System Qualification (2-Day)
This pharmaceutical validation training course provides delegates with an in-depth appreciation of project life-cycle activities associated with equipment system verification / qualification. These activities range from early project planning through to design review and verification / qualification of critical aspects / components of manufacturing systems.
A pivotal theme of the course is a risk-based approach to verification / qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500-13. As a result, System level Impact Assessments, Component Criticality Assessments and the process of identifying critical aspects of manufacturing systems during the design phase are covered in detail.
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 verification / 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.
PLEASE NOTE: There is an option of booking this course as a 4 day course, which includes the preceding Process Validation course. Please refer back to course schedule - click on 'Back to More Events...', at the bottom of this web page.