Friday, 07 September 2018Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company
To fulfill the needs of trending technologies and Life Science needs, a global supplier management
program helps to integrate an appropriate level of assurance that suppliers and vendors are able to consistently supply quality of materials and services that are in compliance with regulatory requirements.
Have you considered whether your integrated supplier management program:
- Is validated to effectively help your company to asses, manage and monitor supplier qualifications, and risk and compliance across your global supply chain process?
- Is consistently producing the expected results for the intended use that your company is continuously seeking?
Friday, 24 August 2018Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA
As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out
, taking an in-depth look at supplier quality management (SQM)
processes for both medical device
and in-vitro diagnostic
medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.
During this webinar
, I laid out the regulatory drivers for medical device supplier quality management and the importance of Quality
in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s.
Tuesday, 14 August 2018Daryl 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?
Friday, 27 July 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Knowing your suppliers is as important as knowing the material they provide. Life Sciences regulators around the globe could not agree more! If you have a product defect, it doesn’t matter who is at “fault”, your supplier or your own organization.
Ultimately regulators are going to hold your organization (the license holder for the finished product) responsible for the quality
of the materials and services your suppliers provide you. This is evidenced in recently updated standards and regulations such as ISO 13485:2016 and EU MDR, or long-standing standards such as 21 CFR Part 820 and Part 211, or ICH Q9 and Q10. However, and more importantly, the only thing the public will see and react to is your product and your brand. It pays to maintain tight oversight of your suppliers
, and not just for compliance
Tuesday, 24 July 2018Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company
Do you have the proper processes 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?
As global outsourcing activities increase, manufacturers should be placing additional emphasis on the control/oversight of their suppliers, and paying attention to potential risks. Poor cost of quality results in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, etc., which impact the bottom line.