4-Hour Virtual Seminar on Risk Assessment Techniques & Tools in the Medical Device industry
Learn The Regulatory Requirements and The Process For Conducting Effective Risk/Hazard Analysis.
Instructor :
Charles H. Paul
Webinar ID:
4387
Date: 8 February 23, WED
Start Time: 9 am PT
Duration: 4 Hrs.
What you will learn
- Risk Analysis Defined, Why Risk/Hazard Analysis is Important
- Regulatory Requirements and Management Responsibility
- Risk Management Process and Procedure
- Risk Management Plan and Documentation
- Risk Analysis Defined, Why Risk/Hazard Analysis is Important
- Regulatory Requirements and Management Responsibility
- Risk Management Process and Procedure
- Risk Management Plan and Documentation
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation and Risk Management Report
- Common Problems – Regulatory and Human Factors
- When is Risk Management Finished?
Course Description
Research suggests that the frequency and consequence of hazards resulting from medical device use far exceed those arising from device failures!
Medical devices must be safe and effective across their entire life span. Medical device manufacturers are expected to identify possible hazards and apply an effective risk management process.
The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle.
ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures.
Objective of this interactive webinar is to leave you with an understanding of what is expected from regulators, to help you use Risk Management as a tool and to share with you the key steps to effective Risk Management.
In this 4-hour interactive virtual seminar, Charles H. Paul, a regulatory consultant for over 20 years, will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis.
Join us now!
Research suggests that the frequency and consequence of hazards resulting from medical device use far exceed those arising from device failures!
Medical devices must be safe and effective across their entire life span. Medical device manufacturers are expected to identify possible hazards and apply an effective risk management process.
The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle.
ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures.
Objective of this interactive webinar is to leave you with an understanding of what is expected from regulators, to help you use Risk Management as a tool and to share with you the key steps to effective Risk Management.
In this 4-hour interactive virtual seminar, Charles H. Paul, a regulatory consultant for over 20 years, will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis.
Join us now!
Why you should attend
Almost every regulatory agency treats risk as a significant aspect of medical device design and life management. FDA, Health Canada, EU Competent Authority, Australia TGA, and Japan MHLW all require a Risk Management process defined and implemented for their medical devices along with Risk Management documentation!
Risk management is part of the medical device design process. Risk management starts simultaneously with the design process. Risk management extends throughout the product lifecycle – from approval and fielding – introduction to the market – to retirement.
The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis.
Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
- The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA.
- It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
- The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
Enroll Now!
Almost every regulatory agency treats risk as a significant aspect of medical device design and life management. FDA, Health Canada, EU Competent Authority, Australia TGA, and Japan MHLW all require a Risk Management process defined and implemented for their medical devices along with Risk Management documentation!
Risk management is part of the medical device design process. Risk management starts simultaneously with the design process. Risk management extends throughout the product lifecycle – from approval and fielding – introduction to the market – to retirement.
The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis.
Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
- The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA.
- It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
- The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
Enroll Now!
Areas Covered
- Risk Analysis Defined
- Why Risk/Hazard Analysis is important
- Regulatory Requirements
- EU MDR and Risk Analysis
- ISO 14971 and Risk Management
- Management Responsibility as it Relates to Risk Management
- Risk Management Process and Procedure
- The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
- Risk Management Report
- Production & Post-Production Activities
- Common Problems – Regulatory and Human Factors
- When is Risk Management Finished?
- Risk Analysis Defined
- Why Risk/Hazard Analysis is important
- Regulatory Requirements
- EU MDR and Risk Analysis
- ISO 14971 and Risk Management
- Management Responsibility as it Relates to Risk Management
- Risk Management Process and Procedure
- The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
- Risk Management Report
- Production & Post-Production Activities
- Common Problems – Regulatory and Human Factors
- When is Risk Management Finished?
Who is this course for
- Quality
- Production
- Compliance
- Engineering
- R & D, management
- Essentially everyone in the organization that is involved in the design and development of medical devices.
- Quality
- Production
- Compliance
- Engineering
- R & D, management
- Essentially everyone in the organization that is involved in the design and development of medical devices.
Instructor Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance and compliance-related problems.
