EG Life Sciences is sharing the news of Eliassen Group’s updated brand. Read more about what this means for us – and our clients.
In the vaccine production process, protecting against foreign matter is crucial. Learn about sources of contamination in vaccines so you can avoid them.
Jennifer Mariani discusses the resistance to change in the heavily-regulated drug industry and proposes Agile and Continuous Compliance as the solution.
Most IVD manufacturers are taking the necessary steps to prepare to comply with the IVDR. Are you ready to meet the IVDR requirements for Certification?
A push for speed and innovation is forcing large pharma companies to exchange less-efficient liner, traditional processes for methodologies like Agile.
Do you know how to handle drug product that is considered “out of specification,” or OOS? Use this OOS guidance in case it ever happens to you.
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.
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.
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.
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.
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.
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.
Biopharma advancement requires the ability to scale your drug manufacturing capacity to support the product lifecycle. Read this post for key considerations.
This paper discusses how to use the principles of root cause analysis in statistical programming and reporting for CAPA. Download the paper now.
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.