EG Life Sciences

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How to Handle Out of Specification (OOS) Results

Posted by EG Life Sciences

Your cold room just went down. Now what?

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Net Promoter Scores: What Do the Numbers Really Mean?

Posted by EG Life Sciences
What are Net Promoter Scores?

Have you heard of Net Promoter Scores? A company’s NPS or Net Promoter Score is a measurement of customer satisfaction.1 These scores are especially useful in the staffing industry, in which feedback isn’t linked to a tangible product, but is instead related to a more subjective service or experience. For example, when a client says their experience with us was “good,” it’s difficult to derive true meaning from that response, especially as the definition of “good” likely varies vastly from client to client. Thus, the staffing industry was in need of a universally understood, tangible measure of a subjective experience. Enter NPS. While NPS surveys can ask a number of questions, the concept truly focuses on only one:

How likely are you to recommend your firm to a friend of colleague?2
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FDA Form 483 vs. Warning Letters: What's the Difference?

Posted by EG Life Sciences

When the FDA inspects a pharmaceutical or biotechnology company’s manufacturing facilities, they can either alert the company ahead of time or show up unannounced. After the inspection is over, the FDA might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.

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The FDA is On-Site! Checklist for FDA Site Inspections

Posted by EG Life Sciences

In our recent blog post entitled Prepping for a Successful FDA Inspection, we discussed the importance of having a Site Inspection Readiness Team always “at the ready” for FDA visits, regardless of whether the visits are scheduled or unannounced. But what happens once the inspectors arrive? You should have a checklist on hand for the key logistical considerations.

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Prepping for a Successful FDA Inspection: Site Inspection Readiness Team

Posted by EG Life Sciences

For pharmaceutical, medical device, and biotech companies, being always “at the ready” for FDA inspections is an absolute necessity. While some inspections are predetermined, others are surprise visits, so it’s critical to have a team and a process in place to ensure you can respond to every inquiry effectively.

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Are you attending PhUSE in Deerfield, IL?

Posted by EG Life Sciences

In case you’re not familiar with PhUSE, it’s an independent organization that serves as a global platform to discuss topics surrounding programming in the regulated environments of the pharmaceutical and biotechnology industries. And on July 21st, 2016, PhUSE is hosting a single day event entitled, “Utilizing Risk-Based Monitoring to More Effectively Identify and Mitigate Risk While Ensuring Patient Safety, Data Quality and Integrity” in Deerfield, IL.

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