Quality Management II


Quality Management for the pharmaceutical, biopharmaceutical, medical device and healthcare industry.

Learning Outcomes

  1. Demonstrate a good knowledge of Quality management Systems required for Current Good Manufacturing practice (cGMP), Good Quality Control Laboratory practice, Validation, Regulatory bodies, Environmental, Health & Safety & Occupation regulations.

  2. Assess and critically review work practices / facilities / equipment to ascertain compliance with various standards and the risk to safety of employees and processes.

  3. Describe the concept of analytical method validation and its critical importance in biopharmaceutical and pharmaceutical QA and QC.

  4. Participate in a quality management audits and make a meaningful contribution to a quality management role.

  5. Prepare and implement a safety statement in compliance with E.U. Directives and National legislation.

  6. Examine the principles of sustainability in the context of the regulated Biopharmaceutical, Pharmaceutical and Medical Device industries and assist in their implementation.

% Coursework 30%
% Final Exam 70%