ISO 14971:2019 Risk Management (Live Online Training)
Course Overview
What you'll learn
– Understand the purpose, benefits and objectives of a detailed plan for risk management and analysis.
– Describe basic concepts of risk management and analysis.
– Identify risks and approaches to their solutions.
– Understand decision making on the acceptability of risk.
– Understand regulatory requirements of risk analysis.
– Use available information to analyze risk.
– Identify qualitative and quantitative characteristics of risk analysis.
– Identify hazards in risk analysis.
– Estimate and evaluate risks.
– Understand what is involved in risk reduction and control.
– Interpret risk analysis reports.
– Plan for risk management.
Who This Course Is For
Recommended for anyone who involved in medical device manufacturing, including:
– Personnel who need appropriate training to be Qualified and work for Medical device – application of risk management to medical devices
– Project team member as to execute the planned tasks as part of quality management system development project team to develop all necessary Quality management functions and applicable risk management tool to satisfy the ISO 14971 and ISO 13485.
– QA supervisor, R&D supervisor, process engineering, process equipment management, plant & facility management engineer,
– Marketing and Sale staff who dealing with the business planning for new product and process development, manufacturing operation and up to top management level.
– All personnel who interests to studying the good practice in implement Medical device – application of risk management to medical devices.
About this course
- This training course includes the lecturing and practical workshop to encourage all attendant learn the principle risk assessment applicable for medical device manufacturing operation compliance ISO 14971:2019:
- The delegate will also learn and practice the interpretation of standard requirement and the application of all standard clause applicable all standard requirement.
- These also include key issue and technical consideration related to product and process characterization, risk involve in design and manufacturing phases, where all risk will be identified, minimized and control through the development of the related manufacturing management system.
- At the end of this training course the attendant will equip with knowledge and practical approach to be able to plan, prepare and implement Medical device – application of risk management to medical devices.
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