Quality Management I

Description

This 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 standardised Standard Operating Procedures, delineate important criteria associated with validation & understand how the CAPA system is used.

Learning Outcomes

  1. Discuss the role and function of Quality within the laboratory and Industry.

  2. Outline the role and function of GLP, Quality Assurance, GMP and Quality Control within the laboratory and industry.

  3. Identify the agencies which regulate quality standards.

  4. Identify the responsibilities of the employee and employer with regard to health and safety in the laboratory and industry.

  5. Construct non-conformance reports and CAPAs for breaches associated with Quality Systems in Biopharmaceutical Science companies.

  6. Design SOPs using laboratory standards and regulatory guidelines.

Credits
05
% Coursework 100%