ISO 14971:2007 Risk Management

Description

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 14971:2007. 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.
 

Objectives

• 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.
• 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.
 

Audience

• Personnel who need appropriate training to be Qualified and work for Medical device

• Project team member as to execute the planned tasks as part of quality management system development
• QA supervisor, R&D supervisor, process engineering, process equipment management, plant & facility management engineer
• Marketing and Sale staff
• All personnel who interests to studying the good practice in implement Medical device