Compliance and Validation Training Courses
Pharmaceutical Equipment System Qualification
This pharmaceutical validation training course provides delegates 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 / critical design elements of manufacturing systems.
A pivotal theme of the course is a risk-based approach to qualification of manufacturing equipment systems, as defined under the ISPE baseline guides and ASTM E2500. As a result, System Classification, System Risk Assessments and the process of identifying critical aspects/critical design elements of manufacturing systems are covered in detail. Underpinning all of this is the understanding of the processes involved and having clear definitions of Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters and control ranges/philosophy, which will be covered in the introductory presentations.
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.
Delegates 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, together with a course dinner, held on the evening of Day 1 (Tuesday 1 Oct 2024), are included in the overall package.
