Product Risk Management Techniques

This webinar will cover Risk Management per ISO 14971 throughout the product lifecycle. Risk Management is an important process to methodically and effectively identifying and mitigating risks in the product design and manufacturing processes. A robust process to identify hazards and associated harm throughout the product life cycle is critical to providing safe and effective products for your customers. This webinar will help you build an efficient and effective process for risk management.

Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements and how to create processes and procedures to implement them. You’ll learned techniques that can help you identify hazards and potential harms. You’ll learned how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious quality problems and costs for your company.

Areas Covered in the Session :

  • Overview and Definitions
  • FDA Expectations
  • ISO14971
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle. Common Mistakes
  • Best Practices

Who Will Benefit:

  • Due Diligence Teams
  • Quality Engineers
  • Compliance Departments
  • Quality Departments
  • General Managers
  • Design Engineers
  • Research & Development Departments
  • Product Development Leaders
  • Product Development Project Managers
  • Auditors

Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance