Articles From Our Expert Network
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What To Expect From A Remote Inspection -- & How To Navigate It
7/23/2021
Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
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The 8-Step Checklist To Write Effective Investigation Reports
7/16/2021
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
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FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
7/14/2021
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
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How To Enhance “Operational Learning” In Biopharma
7/9/2021
According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.
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5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
7/2/2021
Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation.
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Data Integrity In Supply Chain Risk Management During Zero Trust
6/21/2021
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
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The Role Of The Contract Manufacturer Under The EU MDR & IVDR
5/31/2021
As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.
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Major Shift in Demand For Oxygen Therapy Devices – New Study For 2021
5/21/2021
Oxygen therapy is used to treat a variety of medical conditions, such as cancer, cystic fibrosis, and chronic obstructive pulmonary disease (COPD). The market is moving away from traditional cylinder-based methods of oxygen delivery toward what technology? And what type of device has emerged as an exemplary delivery system?
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Harnessing The Power Of AI In MS Diagnosis, Monitoring, And Treatment
5/17/2021
A prime example of the future potential of artificial intelligence (AI) is in revolutionizing the way we diagnose, monitor, and treat multiple sclerosis (MS), thereby advancing our understanding of the disease course. To maximize the utility of AI in MS, drug developers and medtech manufacturers must strategically incorporate AI solutions into their approach to MS drug development and commercialization.
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Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.