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
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
Yesterday was Part I. Today, we get to hear a little more from Barb on her background.
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
This 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
- Is part of your job to prep your company for FDA inspections?
- Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers?
- Is the FDA ORA reading room bookmarked on your browser?
Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we have for new people to get onto the right path?
I turned to you on LinkedIn, and these are some of my favorite responses: Continue reading