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May Dinner Meeting
May 16 @ 5:30 pm - 8:00 pm
Risk Management Jeopardy
Application of risk management defines a standard process for identifying risks associated with all stages in a product’s life cycle, from product design to production and postproduction use. The goal is to develop a risk management plan that is capable of assessing, evaluating, identifying controls, and monitoring the risks associated with each life-cycle stage.
This presentation will cover the following:
- Describe the Risk Management Process as defined in ISO 14971:2019
- Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirement
- Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
- Effective auditing techniques
Angelo Scangas is CEO of Quality Support Group, Inc., an International Consulting and Training organization.
Angelo has a B.S. in Chemical Engineering, M.S. in Manufacturing Engineering and a MBA. Angelo has more than 30 years of experience in the Medical Device, Automotive, Aerospace, Healthcare and Chemical Industries working in quality systems, product development, manufacturing engineering, quality assurance and process improvement. His background includes product development, risk supplier quality, (ISO 9001, AS9100, ISO 13485, IATF 16949) quality system design and implementation, regulatory compliance and FDA submittals.