Supply Chain Posts

Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions

In the past few years, there has been a lot of focus on how organizations manage their suppliers. The reality for most is that their supply chains are getting longer, the need to work through those supply chain is getting shorter, and the regulatory requirements with regard to supplier management are becoming more broadly encompassing.

The most critical medical device regulatory requirements – ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, and EU MDR – have increased focus on the manufacturer’s responsibility for supplier performance. For instance, in the pharmaceutical industry, 21 CFR part 211 and ICH Q10 specifically address the management of suppliers.
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Pharmaceutical Organizations: Are You Ready for the Unexpected?

Pharmaceutical Organizations: Are You Ready for the Unexpected?

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.

This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
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Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week’s post was the first in a two-part series on practical tips for managing supplier risks in the life sciences industry. In the previous post we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
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Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Recently, I had the opportunity to explore practical tips for managing life sciences supplier risks along with Dr. Carmine Jabri of E.M.M.A. International Consulting Group, Aida Markham of QACV Consulting, and Kenneth Christie of VTS Consultants, Inc. This post is the first in a two-part series where we’ll review key takeaways from Pilgrim’s portion of that webinar and presentation. If you’d like to view the entire webinar, you can watch the on-demand version here.
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Global Supplier Performance and the Regulations Driving Change

Global Supplier Performance and the Regulations Driving Change

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

Innovation within the Medical Device industry, and Life Sciences in general, continues to accelerate at an impressive clip with the introduction of groundbreaking new technologies, resulting in an increasing portfolio of medical devices. At the same time, the global healthcare industry is seeing explosive growth in the demand for those products almost as quickly as they hit the market.
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The Supplier Qualification Framework – Assessment, Responsibility, and Control

The Supplier Qualification Framework – Assessment, Responsibility, and Control

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
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Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Recently, Pilgrim co-sponsored a webinar with LNS Research titled “Supercharge Supplier Quality Management for Competitive Advantage.” During the webinar, Dan Jacobs, LNS Research Analyst, provided many insightful data points from his recent research and made the case for focusing on and advancing supplier quality maturity.

The data is clear…and compelling. Almost every organization can achieve significant gains by improving supplier quality management processes and maturity. If you haven’t watched the webinar, you can access it here and see the data for yourself.
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Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
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