Supply Chain Posts

The Benefits of Supplier Management

The Benefits of Supplier Management

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Supply chain risks grow as an organization’s suppliers expand geographically and companies increase offshoring and outsourcing activities. The increasing sophistication in technology, and ever-increasing regulatory oversight, are additional factors in the increased supply chain risk. Resulting supply chain issues are impacting medical device and pharmaceutical manufacturers around the globe, costing billions of dollars in market devaluations, recalls, regulatory fines, and settlements. But supplier management is a viable tool in the arsenal to minimize the risk of those outcomes. (more…)

The Medical Device Regulatory Landscape is Impacting Supplier Control

The Medical Device Regulatory Landscape is Impacting Supplier Control

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Ask any corporate executive to list the top objectives of their organization’s Quality department and they’ll include the need for predictive and proactive risk management strategies. The Medical Device industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk.

One of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage our suppliers, and in many cases our suppliers’ suppliers, thereby increasing overall risk. The plethora of medical device regulatory requirements placed in Medical Device organizations, including FDA mandates and the updates to ISO 13485:2016, reflect this new reality. (more…)

Supplier Risk and its Impact on Corporate Risk

Supplier Risk and its Impact on Corporate Risk

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.

Supplier risk, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain and to the availability of products and services within that supply chain. Supplier impact, at a minimum, two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: Risk and Compliance. It is safe to say then that the impact of suppliers on an enterprise is significant. (more…)

Know Your Suppliers: Protect Your Customers

Know Your Suppliers: Protect Your Customers

Kari 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 reasons. (more…)

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, an IQVIA company

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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Fortifying Quality across your Global Supply Chain

Fortifying Quality across your Global Supply Chain

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

In recent weeks, the Pilgrim Blog has addressed the fact that supply chain complexity in the Life Sciences has grown from simple domestic sourcing, manufacturing and distribution, to a complex ecosystem of global sourcing, manufacturing, and distribution centers around the world. As such, companies need to develop, implement, and maintain a Supplier Management program that integrates compliance, oversight, and strong supplier relationships into business practices and quality systems.

Yet, in many cases today, not all suppliers are selected, evaluated, or maintained according to the type of product or service provided. (more…)

Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Strategic Planning for the In Vitro Diagnostic Regulation (IVDR). Have You Spoken to Your CEO Yet?

Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

Despite having a longer transition of five years compared to the three years for the EU Medical Devices Regulation (EU MDR), the In Vitro Diagnostics Regulation (IVDR) provides IVD manufacturers with a much higher hurdle to jump over than the EU MDR1 for “general” IVD manufacturers. Due to this higher hurdle, IVD manufacturers must not sit back and wait for the commotion of the MDR to die down before implementing their transition.

Adding to the pressure of the May 2022 IVDR transition deadline, other, even shorter deadlines should force IVD manufacturers into action sooner. These include Health Canada’s mandate for adherence to the Medical Devices Single Audit Program (MDSAP), and the end of transition of EN ISO 13485:2016. (more…)

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, an IQVIA company

Earlier this week we shared 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, an IQVIA company

It is critical today that risk-based thinking be embedded across respective quality and compliance activities throughout the Life Sciences. ISO13485:2016 regulations are driving the industry to this paradigm. I recently explored practical tips for managing life sciences supplier risks together with a team of consultants, including 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 that examines our findings, which you also can uncover on-demand here.
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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, an IQVIA company

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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