Description

Learner Profile:

Learners who wish to upskill in advanced technical writing for the manufacturing sector, particularly those who are employed in the Life Science industries of Pharmaceutical Manufacturing and Medical Device (manufacturing or assembly) - where specific regulatory requirements for documentation are required. Learners will be introduced to the importance of data integrity and preparing documentation for auditors.

Learner prerequisites:

Candidates should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English).

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.
• Understand their target audience and identify the regulatory expectations for technical writing and documentation.
• 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.
• 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