Kari Miller Posts

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 ISO 13485 Compliance 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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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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Combination Products: Past, Present, and Future – Part 1 of a Series

Combination Products: Past, Present, and Future – Part 1 of a Series

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

The road to regulatory compliance for Combination Products has been a long one, and we’ve not yet arrived at our final destination.

At a recent AdvaMed Workshop in Washington DC, Pilgrim Quality Solutions, alongside FDA experts, had the privilege to present a Past, Present and Future perspective on Combination Products, diving into topics such as Product Registration (PMA, 510K); the De Novo pathway for Combination Products; Requests For Designation (RFD); Primary Mode of Action (PMOA); Labeling and Cross Labeling of Combination Products; CGMP; Adverse Event Reporting and Post Market Safety Reporting; and, Combination Product Inspections and Quality System Regulations.
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Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

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

Last week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
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Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Global Harmonization and the Link between ISO 13485:2016 and MDSAP

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

Let’s face it. The world of trade is shrinking. It’s no longer enough to design, build, and distribute a product in compliance with the manufacturer’s national regulations. Within each phase of product development, the manufacturer must abide by global regulations as well. If you’re a medical device manufacturer, and you haven’t started looking at ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), you’re running out of time!
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Deviation Management and the Next Level of GMP Compliance

Deviation Management and the Next Level of GMP Compliance

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

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing deviation management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.
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