Regulatory Articles
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management
6/22/2022
This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.
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Steps To Successfully Complete An FDA Inspection
6/20/2022
We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.
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How Early Raw Material Testing Mitigates Product Development & Regulatory Risk
6/7/2022
Materials not subjected to early testing can contain impurities/contaminants that impact downstream biocompatibility issues, which can increase the risk of regulatory hurdles.
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Biological Indicators And The European Pharmacopoeia
5/10/2022
Here, we review the information concerning biological indicators in European Pharmacopoeia General Chapter 5.1.2, which is more detailed and covers a wider scope than the previous version.
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How Effective Training Management Can Help You Prevent Quality Issues
1/28/2022
Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.
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Medtech Manufacturing: From Disruption To Evolution
12/16/2021
Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.
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Vital Signs Of The Medical Device Industry
10/1/2021
The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.
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Why Automation Is Essential For Document Control Compliance
10/1/2021
In medical device development, speed, efficiency, and accuracy with document control processes are a top priority. Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.
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Identifying And Preventing Common Data Integrity Issues
9/30/2021
Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate. A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.