COURSE OUTLINE
Practical workshops throughout the day are also provided in order to give you the opportunity to apply your skills how to implement risk analysis, risk evaluation, risk control, production and post-production activities and risk management review within your organization.
This fully 2-day course is a highly interactive training that includes case study exercises, competency assessment, and Certificates of Completions.
Objectives
- To enable participants to understand the systematic approach towards measuring risks to produce safe and effective medical devices.
- To understand and effectively develop and implement systematic application of management policies, procedure and practices to identifying, controlling, and monitoring risks to conform to the requirements of ISO 14971:2019 How to minimize / reduce errors or deficiencies that was designed into particular devices that may have been prevented by adequate design and development control.
- Enable participants to apply risk management principles within organization
What do participants gain?
Participants of this program will be provided with a basic understanding on the requirements of ISO 14971:2019, the ISO standard which specifically addresses the concerns of Risk Management for medical devices.
Who should attend?
Managers, Engineers, Executives, Supervisors of various departments: Quality Assurance, Production, Regulatory Affairs, Laboratory, Logistics, Purchasing, and Members of the Risk management Team.
Seminar Materials
Seminar Manual with exercise and workshop