QUALITY RISK MANAGEMENT AND IMPACT ASSESSMENT COURSE

Quality Risk Management (QRM) principles require the systematic evaluationof risk, patient safety and product quality based on scientific knowledge, dataand experience.Regulatory bodies expect QRM to be seamlessly integrated into the QualityManagement System (QMS) framework by using the life cycle approach.

Thisintegration involves the implementation of both formal and informal riskassessment tools that support the elements defined in ICH Q9 for riskassessment, control, review, identification and acceptance of residual risks.System impact assessments (SIA) are critical for evaluating impact of newequipment or changes in existing equipment, components, facilities,processes and/or systems, on product quality.

These systems need to be designed to meet the intended use of the productand must be suitable for cleaning, maintenance and operational requirements.This course therefore is designed to offer you support for your own projectsand departments across diverse functions such as regulatory, validations,quality assurance, quality control, production and engineering.