
Principals and Techniques of the Quality Risk Management are required to determine if a Product or Process deviation presents a potential risk to the Patient and if so, how it can be mitigated to ensure the patients safety.
This eLearning course provides the principles and tools which can be used to Manage the Risk to Quality of Medicines which can be applied to different aspects of pharmaceutical quality.
This includes all aspects involved in the Development , manufacture and supply of drug substances to assure the Quality Safety and Efficacy of medicines for Patients
Credits: 4 CPD / CME
No. of Hours: 4 hrs
Learning Objectives:
This course will provide an introduction to the skills and competencies required, to Assess and control out of specification and Product/Process deviation by Quality Risk Management. The candidate will learn how to asses and mitigate risk by using techniques such as Risk cause analysis and failure mode Effect analysis to identify and mitigate the potential risk.
Who Should Enroll:
Persons involved in Pharmaceutical Processes – Product Development, Clinical assessment, Manufacturing , Distribution, Pharmacovigilance, and Dispensing medicines to the patient