Introduction
Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. This module covers the quality risk process including risk assessment, control, communication and review. It discusses risk management methodology such as Failure Mode Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA). Fault tree analysis (FTA) and Hazard Analysis and Critical Control Points (HACCP) as well as Hazard Operability Analysis (HAZOP) are also covered.
This course on Quality Management Systems consists of a number of modules covering different aspects of Quality Management in the health environment. The learner can choose to complete all the modules in the course or only those applicable to his/her working environment. The course is presented as a number of distance modules, each of which has to be completed in 4 weeks from enrolment.
The module concludes with the integration of quality risk management into industry and regulatory operations.
Who Should Enrol
This course is targeted at all personnel working in an environment requiring quality management.
Course Content
Course Highlights
This course provides the knowledge to function successfully in the quality environment.
It covers the topics needed to work within the guidelines set by quality standards and processes (Just-in time, Kaizen, Agile, Six Sigma, Lean), conduct audits, manage projects as well as the supply chain and report on pharmacovigilance. Bioethical guidelines are also covered. The newest module covers the topic of Quality Risk Management (QRM)
Assessment
After completion of the knowledge section, the learner must successfully complete a multiple- choice questionnaire
Certification
To obtain the certificate of completion, the learner must achieve a pass mark of 50%.