EU GDPR: Are You Ready? Is Your Quality Management System, Too?

EU GDPR: Are You Ready? Is Your Quality Management System, Too?

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

EU GDPR — The Week is Here!

The General Data Protection Regulation (GDPR), approved by the European Parliament and Council in April 2016, replaces the Data Protection Directive 95/46/ec at the end of this week, on May 25, 2018. It will become the primary regulation protecting all European Union (EU) data subjects from privacy and data breaches in a world driven by data — a world very different from the time in which the 1995 directive was established. (more…)

Florida Medical Manufacturers Consortium: 2018 Symposium Update

Florida Medical Manufacturers Consortium: 2018 Symposium Update

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

Established in 2003, the Florida Medical Manufacturers Consortium (FMMC) strives to unite, promote, and grow Florida’s Medical Device Industry and enhance the business success of its member companies. To that end, every year the Consortium hosts a Symposium to allow for industry networking, the expansion and sharing of industry knowledge and expertise, and to update its members on advocacy activities.

FMMC’s current advocacy activities occurring at the state and national level include:

  • Supporting Florida legislation fully exempting the purchase of manufacturing equipment (MME) from sales tax
  • Backing proposed legislation to reduce Florida’s sales tax on commercial rent
  • Working with national, regional, and industry advocacy groups in the fight to repeal the medical device excise tax

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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…)

Be Aware! Security Training and Employee Engagement

Be Aware! Security Training and Employee Engagement

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions, an IQVIA company

As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of employee security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
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Document and Change Management: These Siblings Play Well Together

Document and Change Management: These Siblings Play Well Together

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions, an IQVIA company

This is the story of a beautiful family – Mr. & Mrs. Quality Management and their two children, Document Management and Change Management. Unlike many siblings that squabble daily, the Quality family kids play very well together. Their favorite playground is in the Life Sciences where they frequently collaborate to show off their teamwork and agility.

In that arena, the siblings do sometimes demonstrate distinctive personality traits as well. For instance, Document can be overwhelming, and at times, sloppy and out of control; Change is a constant force and can be difficult at times, but prefers to be in control. In those instances, they need to support each other. There’s no denying their relationship, and that they are, in fact, better together. (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…)

Quality Risks: Use Quality System Data to See the Big Picture

Quality Risks: Use Quality System Data to See the Big Picture

Kevin Lee, Industry Solutions Manager, Pilgrim Quality Solutions, an IQVIA company

On a day-to-day basis, most of us are busy taking care of the details. We’re fixing problems as they happen, checking things off to-do lists, and responding to emails. But as we move through our busy days, most of us are aware of the periodic need to take a step back, look at the big picture, and assess our progress against our goals. That high-level look often reveals trends that need to be reinforced or changed as we move forward. Nowhere is this truer than within a quality system. The seemingly small or micro details that we work through each day add up with other processes and details to form the bigger (macro) picture of our organization’s risk.
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ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

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

The global economy is often the topic of blogs, articles, and macroeconomic discussions. It’s no surprise that it’s become a leading consideration in the field of Quality as well. The global economy has added complexity to our supply chains making it more important than ever to assess and control supplier risk. Lengthy supply chains make it more difficult than ever to manage suppliers and remain compliant with the plethora of regulatory requirements around the world. The updates to ISO 13485:2016 reflect this reality.
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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, 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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