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. 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.

Validation of computerised data management and equipment control systems · This course provides attendees with up-to-date and detailed information that should help them tackle the many diverse challenges of validating and operating computerised systems in a compliant and risk based way. The course aims to cover all the key areas that need to be considered when qualifying and operating computerised systems. These include: the types of computer/computerised systems and their elements; key regulations and guidance (including GAMP 5 2nd Edition [2022]); data management and data integrity; the general principles of risk based validation; validation planning/approaches/activities; supplier governance; data migration; current trends; operational phase activities; infrastructure management; and periodic system review. It will also include an example infrastructure project and the qualification of: Packaged Systems (Equipment Control Systems); Distributed Control Systems; Laboratory Systems; Information/Business Systems and Spreadsheets. The presentations will include real life examples and the learning experience will be enhanced by using carefully structured workshops. 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.