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Risk-based Design Control - The New Paradigm for Medical Device Design

  • Training

  • 60 Minutes
  • Compliance Online
  • ID: 4900004
In this webinar, learn about the 2019 approach to compliant design control, how to create, manage, and maintain the information found in the various Risk Management documents and files. Get insights about how to shrink documentation time to provide enough time for actual risk management and mitigation.

Why Should You Attend:

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.

Areas Covered in the Webinar:

  • The 2019 approach to design control
  • What do FDA and ISO say about it?
  • How do you present it to management?
  • What are the key steps in risk-based design control?
  • How to implement risk-based design control in your company
  • Bringing it all together - links to design and process

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control
  • From Medical device and combination product biotechnology devices

Speaker

Jose Mora

Course Provider

  • Jose Mora
  • Jose Mora,