4 Trends About GMP Inspection Readiness and FDA Data Intelligence

rockytimesahead-2I 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

What FDA enforcement trends do you see in your industry?

Barbara UngerThis week, I got a chance to ask our new editor-in-chief of GMP Regulatory Intelligence a few questions. Her responses were so thorough and insightful that we decided to publish her responses in as a series. Today is part I, where we asked her: “What FDA enforcement trends do you see in your industry?” Continue reading

PRESS RELEASE – New Resource for Regulatory Professionals Preparing for FDA Inspections

PRLog – Jan. 26, 2015 – CHICAGO — Today, FDAzilla announced the launch of a new GMP resource for quality, regulatory, and compliance professionals working in the pharm, biopharma, and select medical device industries.

The FDA continues to increase its focus and attention on ensuring the safety of the drug supply in the U.S. Manufacturing facilities are regularly inspected by the FDA for cGMP, or current good manufacturing practices. With an increasingly complex supply chain – more and more drugs consumed by Americans are manufactured abroad, this has grown into a global effort. In 2014, the FDA conducted a record number of inspections internationally, and many experts believe 2015 will only continue in that thread. Continue reading