Event Details
8 hours
Virtual training with presentation and breakout sessions
During this 1-day course, you will learn how to evaluate your organization’s compliance with FDA/ISO requirements for purchasing controls and acceptance activities, consider appropriate risk mitigation strategies for supplied products and services, and implement a life cycle management approach to your organization’s supply chain.
Contact us to get notifications about future courses or to schedule a private workshop.
8 hours
Virtual training with presentation and breakout sessions
This hands-on learning opportunity covers the key aspects of supplier controls – from planning for supplier assessment and selection, to defining acceptance activities and monitoring supplier performance – and links them to the requirements found in the ISO 13485 Standard, pertinent International Medical Device Regulators’ Forum (IMDRF) and Global Harmonization Task Force (GHTF) guidance. During this 1-day course, you will learn how to evaluate your organization’s compliance with FDA/ISO requirements for purchasing controls and acceptance activities, consider appropriate risk mitigation strategies for supplied products and services, and implement a life cycle management approach to your organization’s supply chain.
This course is designed for:
Through training, participants will:
Each topic is presented from a practical perspective, with links to the requirements of the QSR, the ISO 13485 Standard, risk management considerations, and pertinent GHTF guidance
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
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