Online Training Courses

3-day course: Design, commissioning and qualification of pharmaceutical critical utility systems · This pharmaceutical training course covers current and best practice in the areas of design, construction and commissioning / qualification of critical utility systems. It includes generation and distribution systems for purified water, water for preparation of extracts and water for injection (WFI), clean steam, pure steam, compressed air and process gases. The course provides an insight into the underlying hygienic design principles/requirements/guidance involved in the specification, construction and completion of these systems. Testing requirements (qualification and routine) are also covered. It also provides information on suitable system design solutions and configuration, together with a detailed systematic approach to the key stages (including planning) involved in the project life-cycle. Typical examples of operational issues and recommended actions/precautions that can be taken, are also covered by this course. The course will be fully updated to reflect requirements from the latest pharmacopoeias and EMA regulatory guidelines, including Annex 1 and the Q & A's for the production of water for injection using non-distillation methods.

2-day course covering a risk based approach to Pharmaceutical Equipment System Qualification · 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.

Design, Qualification and Operation of Temperature Controlled Storage & Distribution Systems · This live online pharmaceutical training course has been tailored to cover a typical life-cycle approach to the design, qualification and operation of temperature controlled storage and distribution systems. Systems, facilities and equipment have been placed into logical groups, which will be taken through their respective life-cycle (design, qualification and operation). The course aims to cover as many types of systems involved in the storage and distribution of drug products as practicable in the allotted time (controlled temperature and cold chain), taking care not to overload the information. The course includes new sections on operational considerations for each system/facility/equipment group, with ongoing risk management, continuous improvement, data reporting/management and dealing with non-conformance, e.g. failure to include shipment loggers, lost loggers and logger failure. So to sum up the course, we take people through system/equipment/facility design + selection for compliant and consistent operation, how to qualify the systems/equipment/facilities (with example approaches) and then through ongoing operational considerations for compliant and consistent operation.