Don’t Be Shortsighted When Evaluating eQMS Solutions

Don’t Be Shortsighted When Evaluating eQMS Solutions

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions

As a Sales Engineer for over a decade, I continually engage with clients through every step of the sales cycle, from the initial inquiry and Request for Information (RFI) phase, all the way beyond the selection of software solutions. Over the years, I have observed companies engage in a tremendous range of software selection strategies.

Distilling down all of those observations has revealed the one main factor that I truly believe creates a successful evaluation process, one that establishes a lasting partnership between a client and a vendor. That factor is whether a company enters into the evaluation process with a long-term vision for organizational quality versus simply conducting a point solution selection.
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Combination Products: Past, Present, and Future – Part 3 of a Series

Combination Products: Past, Present, and Future – Part 3 of a Series

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

In the first two parts of this series, Combination Products: Past, Present and Future, we reviewed the historical path of combination products and the complex road to regulatory and quality compliance for this product category, leading up to today’s current state. It is important to recall that Combination Products is its own product category, independent of Medical Device, Drug, and Biologics. We discussed that fact that combination products have their own cGMP (21 CFR Part 4), but the cGMPs of the constituent parts (i.e. devices, drugs, and/or biologics) must not be neglected either.
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Combination Products: Past, Present, and Future – Part 2 of a Series

Combination Products: Past, Present, and Future – Part 2 of a Series

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

In Part 1 of this series, Combination Products: Past, Present, and Future, we focused on the past, a necessary step in understanding just how far we’ve come in this space. We also reviewed the definition of a combination product before strolling down origins lane, to ensure proper focus. As witnessed through the lens of history, the road to regulatory and quality compliance for combination products was and is a complex one, and in many ways, the regulatory path for these products is still under construction.
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2018 Resolutions: Make Quality & Compliance Collective Top Priorities

2018 Resolutions: Make Quality & Compliance Collective Top Priorities

Do you ever wonder how many individuals truly commit to their New Year resolutions? How many actually follow through? The figure is difficult to calculate because more often than not, there is no system of checks and balances, no accountability for individuals’ behavior. In 2018, consider not only your own personal Quality and Compliance goals and resolutions, but engage your colleagues in sharing them with you. Be one another’s support network and ensure that those intentions are realized. Make the behaviors that support them a part of your organization’s Quality Culture for 2018.
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Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a delightful holiday season and a prosperous 2018.
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Not-So-Standard SOPs: What You Need to Know

Not-So-Standard SOPs: What You Need to Know

Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions

Formal written Standard Operating Procedures (SOPs) are required both by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why.

However, for the last couple of years, SOP deficiencies have been one of the top findings in FDA audits on both the drug and device manufacturing sides. In fact, almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs, or lack of compliance in following them, within an organization. As such, the entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects or mismanagement of the related processes.
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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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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

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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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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