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.
The true value of GMP Regulatory Intelligence lies not in the collection of documents that can be automated with various software, but in its synthesis and analysis. It is most valuable to be able to link a compliance action to a newly published regulation or guidance or to be able to discern how guidance on a specific topic differs between US and EMA guidance. Tracking the actions taken against multiple sites of a single company can be an important way to discern the compliance status of that organization and the serious concerns of the inspecting agency. An overwhelming amount of information is publicly available, the challenge is to be able to synthesize it and make conclusions that can lead to meaningful actions. Otherwise, firms can end up with a vast collection of data, but lack information and knowledge.
Give us a quick summary of your professional background. What led you to pursue your current career?
At the beginning of my career I spent time in a couple of research institution laboratories. This time was important because I learned to analyze data and developed the ability to ask specific questions. I then joined a small venture capital company in San Diego where I had the opportunity to learn how this industry functioned as the company grew. I treasure that time because we worked completely without silos, and all pitched in to do whatever needed to be done. I felt like I made a difference. Here I learned how all the pieces of the puzzle actually fit together.
My next positions were in two large pharma / biopharma organizations in CMC Regulatory Affairs and Quality, including corporate GMP audits. I had a couple of mentors along the way who provided guidance and opportunities that allowed me to build expertise in this area. I found I had an interest and ability to analyze GMP guidance and I started out drafting comments on these items for our department director. He encouraged me, and introduced me to several people who provided insight and history on various topics that I could not have gained in any other way. And the rest is history. Most recently, I spent 8 years at my last employer developing, implementing and maintaining a comprehensive GMP Regulatory Intelligence program.
Is there anything you miss about working in industry?
I’ve had the privilege of working with some amazing people, and I miss them. But with the social networks like LinkedIn and email we can stay in touch. Change seems to have accelerated in our industry along with positions being eliminated, consolidated or outsourced. Having a way to stay in touch as we all change jobs and companies is essential to maintaining a network.
Other FDA Inspection resources:
- Free listing of FDA 483s since 2000>>
- FDA Inspector Search>>
- One of the largest 483 stores in the industry>>
- Weekly GMP Regulatory Intelligence Newsletter>>
- 483 PDF subscription service>>
- Full-Text FDA 483s>>
- Enforcement Analytics>>