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  • Product id  :  IQW15C8248

    Medical Device Risk Management

Speaker
: Susanne Manz
Schedule
: Friday, March 10, 2017 | 10:00 AM PST | 01:00 PM EST
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Duration
: 90 Mins
Level
: Basic & Intermediate
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  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker
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 learn techniques that can help you identify hazards and potential harms. You’ll learn 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 problems and costs for your company.  We’ll discuss FDA expectations for Risk Analysis as well as ISO 14971 regulation. This course will also help you understand how Risk Management applies throughout the product life cycle and links to design control, failure analysis, production and process controls, and CAPA.
 
  • Overview of the Regulations
  • Lessons Learned and Common Mistakes
  • Linkages in Your Quality Management System
  • Best Practices
  • Preparing for an FDA Inspection
  • Overview of the ISO14971 standard as it applies to medical devices
  • How Risk Management Fits into Your Quality Management System
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Quality Systems Specialists
  • Design Engineers
  • Quality Engineers
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • Quality/Compliance managers or directors for Medical Device companies
  • R&D Leaders
  • R&D Project Managers
  • General Managers wanting to learn how to understand Quality System requirements

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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