Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company
When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:
- Do you have the proper process in place to evaluate, monitor, track, and rate your suppliers?
- How confident are you that you can rely on your suppliers or even that you are protected from issues your suppliers encounter at any of their locations?
Since the launch of this series and meeting with customers regarding Pilgrim’s SmartSolve® Supplier Management module, another question has arisen: “How would I know?”
We’re finding that a lot of medical device organizations we interact with are confident that they are doing the right things to ensure quality parts are being used to manufacture their devices. What is causing uncertainty is whether or not those ‘right things’ are enough to protect them from a regulatory standpoint.
Anyone with this question, should be attending the 2nd installment of the Quality In, Quality Out webinar series on August 15th, or register to receive the recorded presentation afterward.
Once again, Phil Johnson, Senior Principal of Quality and Compliance Services for IQVIA, will talk about supplier quality management (SQM), with a focus on the regulatory drivers of SQM for Medical Device manufacturers. Next month, Part 3 of the series on September 19th will focus on regulatory drivers of SQM for Pharmaceutical manufacturers.
This installment of the webinar series will address:
- Supplier quality management regulations
- 21 CFR Part 820 (established process)
- ISO13485:2016 (changes and impact)
- MDSAP (what to expect during an audit)
- Responsibilities of legal manufacturers and suppliers
- Changing needs for OEM suppliers and virtual manufacturers
- Applying a risk-based approach to SQM
- From regulations to practical processes
- FDA metrics for SQM
The webinar will have a flow that defines the regulations and lays them out in a way that is easy to understand. The regulations will then be applied to how business is done today, tying the regulations back to modern technology and supply chains. This will be followed with some practical processes that can be enacted to create that ‘risk-based’ approach to SQM. Finally, the presentation will bring it all together by highlighting the prominence of SQM-related FDA 483s.
If you are looking for additional information about your responsibilities as they relate to medical device supplier quality management, or just want to learn more about the topic, join us for tomorrow’s webinar: Quality In, Quality Out: Regulatory Drivers of Supplier Quality Management in the Medical Device Industry.
Quality In, Quality Out
Webinar – August 15, 2018
Regulatory Drivers of Supplier Quality Management in the Medical Device Industry (Part 2 of 4).