2017 Posts

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 happy 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, an IQVIA company

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, 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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FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company

The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv, this information may not be readily available unless you visit the FDA Gateway website to see the full list of the planned updates.

In the interim, there are key updates that will impact various components of the submissions process.
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Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions, an IQVIA company

Think about your quality system. When you initially automate a quality process, you begin by determining the ideal process flow, data you wish to capture, check points to be recorded, and how information should flow between members of your team.

But what about the intersection of where a quality process ends and another business process begins? Some of these intersections may be critical checkpoints between quality and compliance processes and the rest of your business. Notifying Quality about customer complaints, updating Production with nonconformance dispositions, or providing access to documents that need to be referenced from quality records are just a few of the examples of where quality systems interacts with the rest of the business in real-time.
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CDER Metrics Don’t Have to be Frightening

CDER Metrics Don’t Have to be Frightening

Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

The FDA’s CDER Metrics program is set to launch early next year. Although this initiative is voluntary in 2018, it signals a new direction for how the FDA will approach future compliance and inspection practices. A risk-based, data-driven approach will become key to ongoing compliance and success. It’s important to understand and prepare for the upcoming CDER Metrics initiative even if you’re not yet ready to participate.
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ISO 13485:2016 Audit Readiness: Your Questions Answered

ISO 13485:2016 Audit Readiness: Your Questions Answered

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions
Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

Last week, Pilgrim hosted a webinar titled “The Ultimate Guide to ISO 13485:2016 Assessment Readiness.” During the session, we presented comprehensive tips, best practices, and solutions to ensure that your team is prepared and confident when the assessor arrives. If you weren’t able to attend the live webinar, you can access the on-demand version here.

ISO 13485:2016 is a critical topic for medical device manufacturers, and we were delighted to address many questions on assessment readiness at the end of the presentation. Here are 5 interesting questions (with answers) from the webinar’s Q&A session that will help you better prepare for your assessment.
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Make the Move: Solutions for Next-Generation QMS

Make the Move: Solutions for Next-Generation QMS

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

More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization’s culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.
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The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

Sandy Carson, Marketing Manager, Pilgrim Quality Solutions

The industry continues to be buzzing about ISO 13485:2016, and with good reason. The March 1, 2019 deadline is inching ever closer and some organizations are in full preparedness mode. Some have already even conducted mock audits. Others have been granted new product approvals with the new ISO criteria already coming into focus for them. Others are simply putting team plans in place for their implementation and/or upgrade to ISO 13485:2016-ready Quality Management Software (QMS) solutions.
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