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Smart Manufacturing + A Risk-Driven Approach to FDA Inspections

October 21, 2016 / by Emily Ysaguirre

This week’s roundup consists of the LiLS-Roundup-verse-small_2.jpgfe Science industry and what’s going on this month. We have an article from LNS Research on how to achieve smart manufacturing, an article from Quality Digest on how the FDA is enhancing their approach to drug review and development and our own post on how to prepare for, manage and follow up an FDA inspection with a risk-driven approach.

Start with Manufacturing Transformation to Achieve Smart Manufacturing

Author: Andrew Hughes via LNS Research

This article depicts what manufacturers should be doing to improve operations and prepare for an unknown future in a competitive market. It includes an eBook link that provides hints and what automated factors should be included to step towards better operations and a more accurate state of manufacturing information. For more information, read the article in full here.


The Patient’s Voice Enhances FDA’s Approach to Drug Review and Development

Author: Theresa M. Mullin via Quality Digest

This article brings the topic of drug development to light. The author states that recently, the FDA reached a particularly gratifying milestone in important work with patient-focused drug development. It then goes on to discuss that drug development has advanced in the 21st century and how sponsors are using sophisticated and vital forms of technology to generate medicines for the future. For more information on how this has to do with listening to patients and determining ways to reliably capture their perspectives and better integrate them into decision making, read more here.


How to Prepare for, Manage and Follow-up an FDA Inspection: A Risk-Driven Approach

Author: Emily Ysaguirre via Verse Blog

Life Science organizations create products and devices meant to improve quality of life of consumers. Whether these goods are produced on-site or are imported it is important that they are properly created. Device Manufacturers are often challenged with the maintenance of quality goods as well as FDA compliance.

Having Compliance Management Software to ensure regulatory compliance and automate business processes is critical to these organizations.

The importance here is that not only are these goods meeting necessary standards, but that they are given the individual attention necessary to mitigate risk. The FDA must properly be informed by an organization of all reportable adverse events in order to ensure this standard.

The FDA inspection is one of the critical measures of your quality system and your organization as a whole. Read more.

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