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How to Handle Out of Specification (OOS) Results

Posted by EG Life Sciences
Do you know how to handle drug product that is considered “out of specification,” or OOS? Be prepared in case it ever happens to you.

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Net Promoter Scores: What Do the Numbers Really Mean?

Posted by EG Life Sciences
Net Promoter Scores are derived with one basic question in mind: How likely are you to recommend your firm to a friend or colleague? This blog post explains what an NPS is, how it’s measured, and what this number actually tells you.

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FDA Form 483 vs. FDA Warning Letters: What's the Difference?

Posted by EG Life Sciences
After the FDA inspects a company’s manufacturing facilities, they might send an FDA Form 483 or an FDA warning letter. Find out what to expect from both.

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

Posted by EG Life Sciences
Is your Site Inspection Readiness team prepared for FDA visits, especially when they are unannounced? Make sure you have this FDA audit checklist on hand.

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The Risks of Insourcing All of Your Programming & Statistical Analysis

Posted by Antony Goncalves
Companies in regulated spaces have to be able to quickly respond to changing market needs, and they must do so in a way that ensures compliance with governing bodies. For these businesses, the decision of what to keep in-house vs. what to outsource is even more critical and sensitive in nature.

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Prepping for a Successful FDA Site Inspection: Readiness Team

Posted by EG Life Sciences
For life sciences companies, FDA inspection readiness is a necessity. Some FDA site inspections are surprise visits, so it’s wise to have a plan in place.

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Preparing to Comply with the EU MDR

The EU's MDR will significantly impact the process and priorities of medical device companies, with a reinforced focus on patient safety. Organizations affected by the MDR need to take steps now to adhere to new requirements.

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Focus on Compliance: Scale Your Drug Manufacturing Capacity to Support the Product Lifecycle

Posted by Mandy Gervasio
Biopharma advancement requires the ability to scale your drug manufacturing capacity to support the product lifecycle. Read this post for key considerations.

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Beyond "Just Fix It!" Application of Root Cause Analysis Methodology in SAS Programming

Posted by Nagadip Rao
This paper discusses how to use the principles of root cause analysis in statistical programming and reporting for CAPA. Download the paper now.

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A Total Error Approach for the Validation of Quantitative Analytical Methods

Posted by Anagha Kakade
A total error approach can assist with lab data analysis, clinical trials, or the testing of new drugs in the pharmaceutical industry. Learn more here.

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Attend "Core Components for Contamination Prevention & Control in Biopharma Manufacturing Operations"

Posted by Stephen Fochios
Attend the breakfast on April 4 at MassBio - "Core Components for Contamination Prevention & Control in Biopharma Manufacturing Operations" with Gary du Moulin

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Data Visualization: The Epilepsy Story

Posted by Surabhi Dutta
In this paper, Data Visualization: The Epilepsy Story, we tell the story of epilepsy based upon the exploratory analysis and visualization of data for clarity.

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Who's leading in biotech in 2017? East Coast vs. West Coast

Posted by Stephen Fochios
Learn more about the biotech expansion occurring in California and how Massachusetts' life sciences is spurring this growth. What's on the horizon for 2017?

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The Process Validation Life Cycle

Posted by Alan Greathouse
A lifecycle approach to process validation follows the product and the process throughout its life. Learn how critical this is for life sciences companies.

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How to Handle Out of Specification (OOS) Results

Posted by Stephen Fochios
How can pharmaceutical companies handle out of specification (OOS) results related to manufacturing? Read our blog post to determine the steps you need to take.

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