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.

3-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. 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.

3-day course on the use of RABS and Isolator Technology in Aseptic Processing · This course covers the design, installation, qualification and operation of isolator systems and restricted access barrier systems (RABS), as used in aseptic manufacturing. It looks at the choices of systems available and the advantages and disadvantages of using Isolators and RABS over traditional Aseptic Manufacturing. The course also covers system design (types of systems, ergonomics, air classification and air-flow requirements) and the qualification / verification of the equipment systems involved, including facility and HVAC systems for isolators/RABS and surrounding/supporting areas. Also included in the course, is the development, optimisation and qualification of sporicidal decontamination cycles, together with requirements for operation, maintenance, testing, inspection and monitoring of the systems and environments involved. The impact of the new EU Vol.4 Annex 1 (Aug 2022) on the design, qualification and operation of RABS/isolator systems will be discussed, together with the latest developments in gloveless automated isolators. 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.

COURSE CANCELLED - Types of Packaging & Equipment, Security, and Qualification/Validation · SORRY, THIS COURSE HAS BEEN CANCELLED BECAUSE OF UNFORSEEN CIRCUMSTANCES. The course will run next on the 2, 3 and 4 September 2025. Please see our Online Course Dates page for more information.

Sorry, This course has been cancelled. · SORRY, THIS COURSE HAS BEEN CANCELLED. The next course will be hotel based and run on the 18th, 19th and 20th November 2025 at the Scandic Copenhagen Hotel - Please see our Hotel-Based courses. This pharmaceutical training course covers typical life-cycle approaches to the design, qualification and operation of temperature controlled storage and transportation systems, facilities and equipment. Systems, facilities and equipment have been placed into logical groups and attendees will be taken through their respective life-cycle (design, qualification/validation and operation). The course aims to cover the common and latest systems involved in the storage and transportation of drug products. It includes detailed information concerning how to map internal conditions across the spectrum of storage and transportation conditions used in the pharmaceutical industry. Also covered, are the wide range of instrumentation available for monitoring and mapping and how the placement of monitoring probes can be linked to/integrated into the mapping exercises undertaken as part of the validation life-cycle. The potential adjustment of upper and lower limits for storage conditions, to allow for instrument uncertainty, will be covered as part of the instrumentation presentation. The course will also focus on operational considerations for each system/facility/equipment group, covering subjects such as ongoing risk management, continuous improvement, data reporting/management and dealing with non-conformance, e.g. temperature excursions. There will be multiple interactive exercises to break up the presentation material and reinforce learning throughout the course. 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.

Facility Design/Layout; Contamination Control; Risk Assessments; APS; Behaviours/Practices; EM · The course covers one of the most challenging and high risk activities undertaken by the pharmaceutical and bio-pharmaceutical industry. To operate effectively in the field of aseptic manufacturing, it is essential to understand the sources/basic mechanisms of contamination in conjunction with the associated systems and procedures required to effectively control such contamination. This course provides attendees with an in-depth appreciation of contamination sources and mechanisms, together with effective controlling and monitoring mechanisms such as: good cleanroom operation; effective facility/HVAC system design, operation and maintenance; good aseptic behaviours/disciplines; effective personnel clothing systems, sterilisation processes, Aseptic Process Simulation (APS), risk management initiatives and environmental monitoring. All the latest regulatory requirements are built into the course's presentations. 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.