Quality Management I
This module will provide the student with an introduction to Quality Management. The module will equip students with a number of tools that are essential components of a good manufacturing practice compliant company. Students will learn how to draft a Standard Operating Procedure and populate a CAPA form based on a sample Non Conformance.
Discuss the role and function of Quality within the laboratory and Industry, and differentiate between QA and QC.
Outline the role and function of GLP, GCP, GMP in the context of the drug development life cycle.
Construct Standard Operating Procedures, non-conformance reports and CAPAs in line with regulatory guidelines.
Appreciate the growing dependance on automated systems, software and data in a manufacturing context and the importance of equipment and automated system validation and data integrity.
Identify the responsibilities of the employee and employer with regard to health and safety in the laboratory and industry.
Recognise opportunities for more sustainable practice within industry, specifically with respect to electronic record and data management.