Technical Writing – Regulatory Aspects with Irish Quality Centre (IQC)
Overview
This practical programme focuses on the regulatory expectations associated with technical writing in GMP environments.
Prior to attending, participants will complete pre-read materials covering the fundamentals of effective technical writing, including document structure, grammar, clarity, and writing principles. This foundational knowledge allows the programme to focus on the regulatory aspects of technical writing and the application of documentation requirements within regulated environments.
Through industry examples, case studies, and practical exercises, participants will learn how to identify documentation risks, evaluate deficiencies, and produce compliant, inspection-ready documents that meet regulatory expectations.
Key topics covered
By the end of this programme, participants will be able to:
- Apply regulatory expectations to GMP documentation throughout the document lifecycle
- Assess documentation from an auditor and inspector perspective
- Identify common documentation deficiencies and compliance risks
- Critically review SOPs, deviations, investigations, and technical reports
- Apply the principles of ALCOA+ and data integrity to written records
- Produce clear, compliant, and inspection-ready documentation
- Understand the opportunities, limitations, and compliance considerations associated with Artificial Intelligence (AI) in technical writing
Participants will take part in activities including:
- Review and improvement of GMP documentation
- Assessment of SOPs, deviations, and investigation reports
- Analysis of regulatory observations and inspection findings
- Identification of documentation deficiencies and compliance risks
- Group discussions and document review workshops
Who should attend
This programme is suitable for personnel involved in the preparation, review, approval, or management of GMP and regulatory documentation, including:
- Quality Assurance professionals
- Quality Control personnel
- Manufacturing personnel
- Validation professionals
- Regulatory Affairs professionals
- Technical and process specialists
What do Attendees Obtain on Completion?
- Greater awareness of regulatory expectations for written documentation
- Improved ability to assess document quality and compliance
- Enhanced document review and technical writing skills
- Increased confidence in preparing inspection-ready documentation
- A better understanding of documentation’s role in quality and compliance
Participants will receive a Certificate of Attendance from NIBRT and IQC.
Register
Course Format
Onsite Training at NIBRT
- 1 day onsite training at NIBRT facility
Dates & Price
Dates:
- Course 1 30/11/2026€685.00
12 Places Remaining
