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In many industries Validation is defined as the documented evidence that a procedure, process and activity will consistently lead to the expected results. It often contains the Qualification and Validation of Systems, Utilities, Equipments, Facilities and Processes. It is a requirement for GxP (where x = Manufacturing/Clinical/Laboratory/Distribution) and other requirements. Validation is according to FDA's "Establishing Documented Evidence that provides a high degree of assurance that will consistently producing a process specifies a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will ensure a high level of assurance that each step, process and change is well assessed before the implementation takes place. Manufacturing Execution Systems (MES) bridging the information GAP between ERP systems and Process Control Systems. When these systems are used in a GxP regulated environment, these systems are subject to validation. ISPE GAMP ® issued by the Good Practice Guide (GPG) is on this topic The first training is a summary of GAMP®5 and ISA-95. Followed by the GPG, which explains in a practical way how to Validated your MES. Prior knowledge of Validation according to GAMP® is required. If not present, we recommend to follow our training Computer Validation accoording to GAMP®5 & Data Integrity first. Who should attend this training This training is specially designed for Validation and Quality Assurance staff, Engineers, ICTer, Project Managers, Process Engineers and others who are interested in MES Validation according to GAMP®. If non-Dutch students participate, the training will be in English language. General information
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Registration You can register for this training using our Training Schedule For information please contact René van Opstal, phone +31 (0) 6 53630698 or email |
Project & Quality Training International
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