Quality Systems Documentation

In the highly regulated pharmaceutical, healthcare and medical device industries the documentation and records generated within the scope of the Quality System are critical. It is very important that all quality documentation / records are generated in a correct, consistent and complete manner. This course aims to cover many of the routine ‘reports’ which need to be generated within a regulated environment – validation protocols and reports, deviations and corrective / preventive action and batch release documentation. Industry today also demands that technical personnel generate and analyse significant amounts of data and results. Much good work is not recognised through poor communication and technical report writing skills. This course aims to assist technical staff in the generation of professional and well structured technical reports.

At Course Completion:

Course Objectives: РUnderstand the importance of Quality System documentation. РUnderstand how to generate Laboratory equipment validation protocols and reports. РUnderstand how to document deviations – corrective and preventive actions. РUnderstand the importance of Batch Documentation and its functions. РGeneral Report Writing РUnderstand the importance of gathering data/ results into report format. РUnderstand the aims of the report and the receivers of the report. Capturing the interest of the reader. РUnderstand the importance of document structure. РUnderstand the importance of spelling and grammar. РUse of flowcharts, diagrams, tables, appendices to simplify reporting РImportance of conclusions. Course Programme: РOverview of Quality System Documentation РValidation – protocols and reports РDeviations and corrective / preventive actions РBatch Documentation РGeneral Report writing

Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee.