SKILLS TO COMPETE Quality and Good Manufacturing Practice
The aim of the course is equip the learner with the knowledge, skill and competence to perform a range of manufacturing tasks in compliance with quality standards and good manufacturing practice.
Start Date: 16-09-2024 Hours/week: 06 Hrs 00 Mins Duration: 9 weeks
N/A
Age Requirements
Applicants must have reached the current statutory school leaving age
Learning Aptitude
Good numerical and communication skills are essential including verbal and written command of the English language.
Previous Experience
Currently employed in suitable industry or successfully completed the Introduction to the Pharmaceutical Industry Night Class
| Module | Award | Body |
|---|---|---|
| Quality And Good Manufacturing Practice (5N1959) | Quality & Good Manufacturing Practice (5N1959) | QQI |
| Induction (Evenings) | – | – |
1 Outline the regulatory framework applicable to the life sciences sector including the range of regulatory bodies and key legislative requirements
2 Explain the principles of quality and good manufacturing practice compliance systems, as
applicable to the life sciences sector
3 Explain key elements of a quality management system in the context of organisational structure,
responsibilities, procedures, processes, and resources
4 Analyse the relationship between quality systems, good manufacturing practice and manufacturing operations
5 Distinguish between conforming and non-conforming products and work practices
6 Complete required documentation in accordance with quality practices and procedures in the workplace
7 Implement current good manufacturing practice in relation to appropriate dress code and or personal protective equipment in accordance with regulatory requirements
8 Apply standard operating procedures demonstrating an appreciation for their significance and the
processes required to follow them
9 Implement appropriate corrective action, preventative action (CAPA) in line with standard operating procedures
10 Carry out a range of operational or manufacturing tasks in accordance with appropriate procedures and regulations.