Technical Document Writing Training Course (GDP02)
This one day course provides participants with the tools to be able write clear, concise procedures and validation protocols. It provides practical tips on the how best to structure a Quality Management System and the documents therein. The course includes a number of practical tips and useful resources.
This course is designed for all people who work in the Life Sciences industries, and are required to create, complete and/or review documents.
For example;
- All Quality Assurance personnel
- All Quality Control personnel
- All Operational and Manufacturing personnel
- Technical Specialists new to the GxP regulated industries
- Validation personnel
- Technical Document Writers
As the Australian Code of Good Manufacturing Practice for Medicinal Products states;
“Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, Manufacturing Formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance.” Chapter 4 Documentation.
Learning Objectives and Course Description
This course includes:
- understand the importance of good documentation practices
- know how to construct and author effective GMP compliant documents
- be able to incorporate modern learning techniques into their documents and reduce rudimentary documentation errors caused by ill designed documents
- ensure compliance during TGA / FDA audits
- the importance of good documentation practises
- how GDP can save your business unit time and money
- construct and author effective GMP compliant documents
- incorporate modern learning techniques into their documents and reduce rudimentary documentation errors caused by ill designed documents
- minimise documentation errors and ‘KPI’ hits for documentation errors
- understand the GMP requirements for documentation formats, templates and documentation systems
- detail documentation hierarchy systems
This one day course is intended to provide participants with practical knowledge on how to write GMP compliant documents.
Benefits include
- learning from skilled instructors who have shared your difficulties with authoring effective documents
- reduced documentation errors and time lost correcting documentation errors
- improved readability of each participant’s documents
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed
View schedule and how to make a booking.
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