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GxP Lifeline
  • 2017-bl-thumb-santas-kitchen

    How Santa’s Kitchen Prepares for an FDA Inspection

    Before Santa can fill the stockings of good children from across the world, he and his elves must be inspected and/or audited by certified auditing bodies and similar organizations from around the world. Why? Because Santa must prove that the sweet treats he manufactures measure up to high quality standards for all children everywhere.

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    FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter

    Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.1 Since then, the centralized research team has significantly changed from only a few stakeholders into a system of many globally distributed contributors. The industry’s documentation has transitioned from paper files to dynamic, integrated systems supporting digital records spanning the bedside to the research clinic. The delivery of healthcare has evolved from the confines of brick and mortar to cloud-based platforms that could only be dreamed of a few years ago.

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  • 2017-bl-coping-with-scoping-page-image

    Coping with Scoping a CSV Audit

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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    Good Communication Skills are Key for Inspection Readiness

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you.

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    The Quality Metrics Journey

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • Why It’s Time to Revisit FDA’s Quality by Design

    Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

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  • Supplier Approval Challenges Under FSMA

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

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  • How to Use Postmarket Surveillance Data to Gain a Competitive Edge

    Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

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  • UDI: When the Rule is Not Enough

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

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  • Failure of Management with Executive Responsibility

    For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS).

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    Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

    There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

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  • CLIA vs QSR (What You Don’t Know Can Hurt You)

    Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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