Course Overview:

The Quality Systems Documentation training course, to be delivered in Limerickk as one-day public programme is designed to provide participants with necessary information, skills and methods for developing quality documentation in compliance with ISO 9001:2008 requirements.

The Quality Systems Documentation programme is also available for delivery as customised in-company training at clients facilities nationwide in Ireland, including Dublin, Cork, Limerick and Galawy.

Pre-requirements

All personnel involved in the generation of Quality systems documentation.

Course Objectives:

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 & reports, deviations & 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.

The course objectives are:

• Understand the importance of Quality System documentation.
• Understand how to generate Laboratory equipment validation protocols & reports.
• Understand how to document deviations – corrective & preventive actions.
• Understand the importance of Batch Documentation and its functions.  General Report Writing 
•  Understand the importance of gathering data/ results into report format. 
• Understand the aims of the report and the receivers of the report. Capturing the interest of the reader. 
• Understand the importance of document structure.
• Understand the importance of spelling and grammar. 
• Use of flowcharts, diagrams, tables, appendices to simplify reporting Importance of conclusions.

Course Programme:

• Overview of Quality System Documentation
• Validation – protocols & reports
• Deviations & corrective / preventive actions
• Batch Documentation
• General Report writing