The Advanced Technical Writing programme is designed to provide learners with the competencies and knowledge to consistently create high quality content for a regulated environment. Participants will be introduced to the importance of data integrity and preparing documentation for auditors. Learners will also gain essential skills to support root cause analysis and corrective / preventative action investigations (CAPA), providing effective reports with a systematic and organised approach.
Aims and Objectives
This programme aims to establish a high standard of technical writing within manufacturing organisations. On completion of this programme learners will be to develop documentation which is factual, coherent, succinct, and readable for an intended audience. The course will incorporate key concepts such as corrective and preventative actions (CAPA), deviations and root cause analysis.
Course Content
Definition of Technical Writing, Good Documentation Practices and regulatory requirements
ALCOA principles, the importance of data integrity and the challenges faced when developing high standard manufacturing documentation
Characteristics of effective technical writing and document design, templates, layout, language and standardisation
The importance of audience recognition and writing for auditors
Technical writing skills required when documenting CAPA investigations and root cause analysis
Learning Outcomes
On completion of this programme the learner should be able to:
- Demonstrate the ability to develop effective technical documents for a defined target audience
- Apply ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate)principles and understand the importance of data integrity
- Ensure all information documented presents with a logical flow and is chronologically organised learning works
- Apply a consistent approach to the structuring of documents and reports
- Demonstrate the ability to write with focus and present information in a clear and concise manner
- Demonstrate an awareness of root cause analysis methodology and CAPA documentation
Other courses options include
- Introduction to Technical Writing for the Manufacturing Sector
- Introduction to cGMP for the Bio-Pharmaceutical Industry
- Introduction to Clinical Trials for the Pharmaceutical Sector
- Introduction to Validation for the Pharmaceutical Sector
- Introduction to Quality Control for Bio-Pharmaceutical Manufacturing
- Certificate in Supply Chain (Special Purpose Award/QQI Level 6 20 credits)
- Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 25 credits)
