Data integrity and the FDA

Data Integrity: The Whole Story

Last week, Barbara Unger shared about the new regulatory expectations regarding GMP Regulatory Intelligence.  Indeed, we have heard that FDA inspectors have started asking people about what processes we have in place to monitor new regulations, guidelines, and developments.  In part, this is why we now offer the GMP Regulatory Intelligence newsletter.

This week, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market cap has been lost because of this one issue.  The crazy part is this – it’s not even close to being a new issue.  As you’ll see, the data integrity story began at least 15 years ago. Continue reading

New Question FDA Inspectors May Ask You at Your Next Inspection

ARE YOU READY-I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence.  It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines.  Here’s what she had to say: Continue reading

THE BIG PICTURE- 5 KEY TAKE-AWAYS FROM

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading

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4 Trends About GMP Inspection Readiness and FDA Data Intelligence

I hope you read our recent post about the backstory of our company, FDAzilla. We’ve come a long way in 5 years. As we plan for the next 5 years, we’ve been preparing for our annual executive team meeting in April.  As such, our team researches and synthesizes the most important trends in which we must respond and adapt well. Continue reading

3 Questions with Barbara Unger

Yesterday was Part I. Today, we get to hear a little more from Barb on her background.Barbara Unger

What publicly available information do you depend on for your job? How do you use that information?

I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information quickly. The ICH and PIC/S websites also publish their guidance in an organized way. Compliance actions taken by FDA and EMA are also published. I also read publications in the major newspapers and several blogs. Sometimes the best information can come from an unanticipated source. Continue reading