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:
3324

Date: 6 September 22, TUE

Start Time: 9 am PT

Duration: 4 Hrs.

What you will learn

  • Why Risk/Hazard Analysis is important
  • Risk Assessment Defined
  • Regulatory Requirements
  • Risk Management Process – The Risk Management Plan
  • Risk Management Documentation
  • Risk Analysis Processes and Techniques
  • Why Risk/Hazard Analysis is important
  • Risk Assessment Defined
  • Regulatory Requirements
  • Risk Management Process – 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

Course Description

Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed.

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.

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!

Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed.

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.

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

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.

Register now!

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.

Register 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.

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.

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