Kari Miller Posts

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…)

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…)

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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Real World Data and Evidence: Promise of Improved Patient Outcomes

Real World Data and Evidence: Promise of Improved Patient Outcomes

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

During the 12th Annual Conference for the Business of Biotech, held at the Moffitt Cancer Center in Tampa, Florida on March 2, 2018, it was no surprise that the theme of the conference was Discovering Tomorrow’s Cancer Cures. With the keynote on Immunotherapy and the impact it’s having on the treatment of cancer, as well as discussions on Adaptive Therapies, and breakthroughs made possible by the 21st Century Cures Act, one could feel the promise of recent and near-future advancements in the fight against cancer.

With all the science-based presentations at the conference, the session titled Real World Data: Mining Gold from a Mountain of Straw drew my attention. The session focused on Real World Data (RWD) and Real World Evidence (RWE), and how to draw insights from both to improve patient outcomes.
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Smart Quality Management: The Impact of Industry 4.0 on QMS

Smart Quality Management: The Impact of Industry 4.0 on QMS

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

Industry 4.0, also known as Smart Factory 4.0, is labeled as the fourth industrial revolution, yet many don’t understand it or how it will impact the things they do; Quality Management is no exception. The Executives in your organization, however, are most certainly monitoring this paradigm-shifting strategy. Quality professionals should be as well. Quality professionals must ensure they are part of their company’s Industry 4.0 dialogue.

As Quality professionals forge into this new era, it’s critical to have a solid understanding of the premise and aspects of Industry 4.0/Smart Factory 4.0, and its implications for production, the extended supply chain, and their Quality Management System (QMS).
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ISO 13485:2016 Compliance: Yes, It’s That Urgent

ISO 13485:2016 Compliance: Yes, It’s That Urgent

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

We’ve been talking about getting ready to meet the ISO 13485:2016 deadline for a while now, urging organizations to perform regulatory gap assessments, get a compliance update plan in place, and execute. In fact, I just reminded everyone again a few days ago in my blog about the steps to take to get compliant prior to March 1, 2019. So do we really need to address it again? Well, yes, because it is that urgent!

Timing Urgency

If your organization is currently certified to the ISO 13485:2003 standard, then it is important for you to know that before March 1, 2019, re-certification to ISO 13485:2016 will be required for your organization. You’re probably thinking that’s over a year away, we’ve got time! But consider this — from personal knowledge I can tell you that you are definitely not alone in the need to get this done within the next 12 months, and the queue for ISO 13485:2016 certification is long! Therefore, if you’re not done yet, or you haven’t even started, get some help to expedite the process.
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ISO 13485:2016 – The Countdown is On!

ISO 13485:2016 – The Countdown is On!

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

How much effort will it take to get your organization ready for ISO 13485:2016? The February 28, 2019 deadline is now just one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Medical device manufacturers that aren’t prepared for the change will need to do some heavy lifting with regard to quality management practices and processes to stay compliant with the updated standards. Do you know the level of effort needed by your organization to get ready for the new version of ISO 13485? Here is some insight on where to start.
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The Need for QMS Transformation & Structured QMS Data

The Need for QMS Transformation & Structured QMS Data

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

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance to one of Quality.

Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System (QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
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Quality Doesn’t Matter! Say it isn’t so!

Quality Doesn’t Matter! Say it isn’t so!

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

Suppose you have just delivered a Quality Management Solution (QMS) to your customers, and immediately afterward, you receive an invitation to a webinar titled “Why Quality Doesn’t Matter.” What do you do? You sign up!

The anticipation of what Dr. Marla Phillips, Ph.D., Director of Xavier Health, Xavier University, might impart based on this webinar title, was exciting, maybe even a little bit anxiety- inducing. After all, quality is what we strive for, and it’s been the focus of industry for decades. In Life Sciences, not only are we striving to improve quality, we are equally focused on ensuring our global regulatory compliance.
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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, an IQVIA company

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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