Online Training Courses

3-day course:Sterilisation processes, equipment operation, maintenance/calibration and validation · This course provides attendees with a rounded appreciation of all aspects of sterilisation, ranging from equipment design and process understanding, through to qualification and maintenance requirements. One key learning objective is to separate the facts from the myths and legends that are sometimes associated with sterilisation processes. This will help ensure that attendees focus on the important science based facts when making risk based decisions when they resume their normal job related activities. Other learning objectives include equipping delegates with the correct knowledge to improve compliance, reducing potential regulatory issues, improving operation effectiveness and maximising the benefits/effectiveness of validation/qualification activities. The course will be presented by industry experts who collectively have worked in all areas relating to the operation and qualification of sterilisation equipment/processes....

Types of rouge, cause of rouge, control / prevention, monitoring and removal of rouge (2 hours) · Rouging is a disturbance of the naturally occurring passive layer of stainless steel, in effect an inversion of the passive layer rich in chromium-oxides to a porous layer rich in iron-oxides. This interactive online course will benefit anyone who is involved in the identification, risk assessment and management of rouge in pharmaceutical or bio-pharmaceutical facilities. This includes; production managers/supervisors, operators, maintenance technicians, engineers, quality assurance and validation personnel. Attendees will gain a detailed, practical understanding of what rouge is, how and why it forms, where it occurs and what problems this gives rise to. Attendees will learn about strategies to control and monitor rouge and methods that can be used to remove it. Speaker: John Welbourn

Materials and equipment requirements, procedures, analysis of results, causes of failure · Spray device coverage testing is a relatively straightforward method of establishing the surface wetting achieved by spray devices. The test often forms an important element of the equipment cleaning validation program. The course includes a description of the materials and equipment required, guidance on related health and safety considerations, an outline of a typical testing procedure, discussion on test results / examples of common causes of failure and discussion of the strategies that could be used to reduce the time and costs associated with testing. This course is aimed at individuals involved directly or indirectly in managing, performing or reviewing spray device coverage testing activities. Target disciplines include production (operators, supervisors and management), quality assurance, validation, technical support and engineering. Presenter: John Welbourn

Health based cleaning limits for pharmaceutical products, APIs, intermediates and cleaning agents · In order to safely operate manufacturing systems that produce multiple products using common product contact parts, it is critical to establish limits for the cleaning process that ensures the safety of the patients. Safe, scientifically justified, risk based and compliant limits will form the basis of the validation of cleaning process and ensure patient safety in terms limiting carryover from one product to another to safe acceptable levels. This course covers: material carry-over mechanisms / assumptions (linked to the theory of contamination and fundamental to calculating limits); establishing health based limits (HBELS) for pharmaceutical products (in accordance with EU guidance); limits for small molecule API’s an their intermediates and how to obtain limits for detergents. Pharmaceutical product and API limits. Also covered, is the conversion of total allowed carry limits to surface area limits related to swabbing areas + correcting limits for swab recovery performance. Worked examples will be included. The course is aimed at individuals involved directly or indirectly in establishing and operating to safe limits for cleaning processes. Target disciplines include validation, quality assurance, quality control, technical support, production (supervisors and management), and engineering. Presenter: Mike James

Criteria for use of a matrix, identification of marker compound(s), number of runs, hold-times · Applying full cleaning validation for every product changeover on multi-product (non-dedicated) pharmaceutical manufacturing equipment can be very time consuming, expensive and pretty pointless, if you have a common cleaning procedure for all/groups of products. Applying a risk based matrix approach, where the cleaning process is validated for the most toxic and least soluble compound (marker compound), optimizes the cleaning validation process and also demonstrates that you understand your products, the residues they leave and the cleaning process itself (other factors such as the most difficult to clean, based on the nature of the residues remaining, may also be considerations). This course covers: assessing your product mix and potential residues (before and after cleaning); applying a risk based approach to marker compound selection; applying limits for residues, determining the number of cleaning runs required and incorporation of clean and dirty hold times. Worked examples will be included. The course is aimed at individuals involved directly or indirectly in establishing a matrix approach to cleaning validation. Target disciplines include validation, quality assurance, technical support and production (supervisors and management). Presenter: Mike James