Instructor :
Charles H. Paul

Webinar ID:
10290

The demand for advanced risk management in the design and production of medical devices is rapidly escalating as technologies evolve and regulatory expectations intensify.

Research shows that the frequency and impact of hazards from medical device use far exceed those from device failures. In response, the FDA and global regulatory bodies are intensifying their focus on risk management, making it a key component of regulatory compliance and patient safety.

This seminar offers an in-depth exploration of cutting-edge tools and techniques essential for identifying, assessing, and mitigating risks in medical device production.

• Medical devices must maintain safety and effectiveness throughout their entire lifecycle.
• Manufacturers are expected to identify potential hazards and implement a robust risk management process.
• The Risk/Hazard Analysis process is critical for identifying risks that could render a device unsafe or ineffective.
• 21 CFR Section 820 mandates comprehensive risk analysis as part of the regulatory submission process and throughout the product lifecycle.
• ISO 14971 is the global risk management standard for medical devices, guiding manufacturers to:
  • Establish a risk management process
  • Identify hazards
  • Estimate and evaluate risks
  • Develop, implement, and monitor effective risk control measures

Objective: This interactive webinar aims to provide a clear understanding of regulatory expectations, demonstrate how to use Risk Management as a vital tool, and share key steps for effective Risk Management.

During this 4-hour interactive seminar, Charles H. Paul, a regulatory consultant with over 20 years of experience, will delve into both the regulatory requirements and the practical process for conducting effective Risk/Hazard Analysis.

• • Coverage includes ISO 14971, risk evaluation techniques, and integrating risk management into the quality management system.

This seminar is designed to equip professionals with the skills to foresee potential risks and implement effective strategies to mitigate them, ensuring product quality and patient safety.

Join us now to enhance your expertise!

The demand for advanced risk management in the design and production of medical devices is rapidly escalating as technologies evolve and regulatory expectations intensify.

Research shows that the frequency and impact of hazards from medical device use far exceed those from device failures. In response, the FDA and global regulatory bodies are intensifying their focus on risk management, making it a key component of regulatory compliance and patient safety.

This seminar offers an in-depth exploration of cutting-edge tools and techniques essential for identifying, assessing, and mitigating risks in medical device production.

• Medical devices must maintain safety and effectiveness throughout their entire lifecycle.
• Manufacturers are expected to identify potential hazards and implement a robust risk management process.
• The Risk/Hazard Analysis process is critical for identifying risks that could render a device unsafe or ineffective.
• 21 CFR Section 820 mandates comprehensive risk analysis as part of the regulatory submission process and throughout the product lifecycle.
• ISO 14971 is the global risk management standard for medical devices, guiding manufacturers to:
  • Establish a risk management process
  • Identify hazards
  • Estimate and evaluate risks
  • Develop, implement, and monitor effective risk control measures

Objective: This interactive webinar aims to provide a clear understanding of regulatory expectations, demonstrate how to use Risk Management as a vital tool, and share key steps for effective Risk Management.

During this 4-hour interactive seminar, Charles H. Paul, a regulatory consultant with over 20 years of experience, will delve into both the regulatory requirements and the practical process for conducting effective Risk/Hazard Analysis.

• • Coverage includes ISO 14971, risk evaluation techniques, and integrating risk management into the quality management system.

This seminar is designed to equip professionals with the skills to foresee potential risks and implement effective strategies to mitigate them, ensuring product quality and patient safety.

Join us now to enhance your expertise!

Ensuring medical device safety and managing risk is a top priority in today’s global regulatory landscape. Across the board—from the FDA and Health Canada to the EU Competent Authority, Australia’s TGA, and Japan’s MHLW—a well-defined and implemented Risk Management process is not just a regulatory requirement but a cornerstone of effective medical device lifecycle management.

This crucial process spans from device design to market introduction and even retirement, embodying the proactive steps needed to safeguard both patient safety and manufacturer reputation.

By mastering comprehensive Risk/Hazard Analysis, you can prevent medical device recalls or minimize their impact, ensuring your products remain compliant and safe.

Why Attend?

Charles Paul, a seasoned industry leader, provides in-depth guidance on utilizing state-of-the-art risk management frameworks and tools. Attendees will gain practical skills to implement robust risk management processes, ensuring that products meet stringent safety standards and regulatory requirements.

In this seminar, you will:

• • Understand the fundamental principles of risk management as mandated by global regulatory bodies—essential knowledge for any professional in the medical device sector.
  • Learn a structured risk management process, from identification and evaluation to mitigation, ensuring your devices meet the highest standards of safety and efficacy.
  • Explore advanced tools and techniques for Risk Analysis, including Fault Tree Analysis, Failure Mode Effects Analysis, and Criticality Analysis, providing you with practical skills to evaluate and manage identified risks effectively.

Enroll now to transform your approach to medical device risk management. Gain the knowledge and tools necessary to develop safer devices, navigate regulatory requirements confidently, and protect both your patients and your brand.

This seminar is an indispensable opportunity to stay ahead in the rapidly evolving field of medical device safety.

Enroll Now!

Ensuring medical device safety and managing risk is a top priority in today’s global regulatory landscape. Across the board—from the FDA and Health Canada to the EU Competent Authority, Australia’s TGA, and Japan’s MHLW—a well-defined and implemented Risk Management process is not just a regulatory requirement but a cornerstone of effective medical device lifecycle management.

This crucial process spans from device design to market introduction and even retirement, embodying the proactive steps needed to safeguard both patient safety and manufacturer reputation.

By mastering comprehensive Risk/Hazard Analysis, you can prevent medical device recalls or minimize their impact, ensuring your products remain compliant and safe.

Why Attend?

Charles Paul, a seasoned industry leader, provides in-depth guidance on utilizing state-of-the-art risk management frameworks and tools. Attendees will gain practical skills to implement robust risk management processes, ensuring that products meet stringent safety standards and regulatory requirements.

In this seminar, you will:

• • Understand the fundamental principles of risk management as mandated by global regulatory bodies—essential knowledge for any professional in the medical device sector.
  • Learn a structured risk management process, from identification and evaluation to mitigation, ensuring your devices meet the highest standards of safety and efficacy.
  • Explore advanced tools and techniques for Risk Analysis, including Fault Tree Analysis, Failure Mode Effects Analysis, and Criticality Analysis, providing you with practical skills to evaluate and manage identified risks effectively.

Enroll now to transform your approach to medical device risk management. Gain the knowledge and tools necessary to develop safer devices, navigate regulatory requirements confidently, and protect both your patients and your brand.

This seminar is an indispensable opportunity to stay ahead in the rapidly evolving field of medical device safety.

Enroll Now!

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Session Breakup:

• Session 1: 1 Hour 20 Minutes
• Break 1: Energizer Break (10 Minutes)
• Session 2: 1 Hour 20 Minutes
• Break 2: Refreshment Break (10 Minutes)
• Session 3: 1 Hour

Agenda:

• 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?

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Session Breakup:

• Session 1: 1 Hour 20 Minutes
• Break 1: Energizer Break (10 Minutes)
• Session 2: 1 Hour 20 Minutes
• Break 2: Refreshment Break (10 Minutes)
• Session 3: 1 Hour

Agenda:

• 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?

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

The following benefits from watching this. Even better when done as a group!

• • Regulatory Affairs Manager
  • Quality Assurance Manager
  • Risk Management Specialist
  • Medical Device Engineer
  • Product Development Manager
  • Compliance Officer
  • Clinical Affairs Manager
  • R&D Engineer
  • Quality Control Analyst

The following benefits from watching this. Even better when done as a group!

• • Regulatory Affairs Manager
  • Quality Assurance Manager
  • Risk Management Specialist
  • Medical Device Engineer
  • Product Development Manager
  • Compliance Officer
  • Clinical Affairs Manager
  • R&D Engineer
  • Quality Control Analyst