Category Archives: leadership & management

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

5 Ways to Prep for A Regulatory Audit: A Holistic Approach

Greg HattoyToday’s post is written by guest blogger Greg Hattoy.  Greg is a regulatory compliance specialist and insightful industry writer at his blog, Greg takes a distinct approach to regulatory issues and shares his innovative vision for the direction of the pharmaceutical industry

As a regulatory professional, lately it has becoming glaringly apparent that the only way to be successful in a regulatory audit is to take a holistic approach to quality. Holistic can be simply defined as ‘emphasizing the importance of the whole and the interdependence of its parts’. Like holistic medicine, for a ‘healthy’ status with the regulatory agencies, a company, with all their individual components, must be firing on all cylinders in regards to compliance with the greater goal of quality. Now I fully understand this may sound like hippie nonsense, but before the incense candles, spirit crystals, and kumbaya songs come out, let me further explain this thought. Continue reading

FDA After the Election—Part 2: Leadership and Change

Apart from an occasional reference, FDA is not part of the campaign dialogue leading up to the November 6 nationwide U.S. election. Yet, FDA Matters believes that FDA will be strongly impacted by the election’s outcomes.  Part 1 of “FDA After the Election” concentrated on the agency’s budget situation.

Part 2 of “FDA After the Election” focuses on leadership and change–directly and as they may be affected by potentially large budget cuts. There are some predictable elements, but other elements with great impact may depend upon the perspective of those in power for the next two years and beyond. Continue reading

Top 10 Responsibilities of the Pharma Quality Unit

The pharmaceutical Quality Unit has been the target of many FDA Warning Letters as the underlying cause of product quality and CGMP compliance problems. We have seen instances where the ultimate “no confidence” vote is cast when third-party experts are either recommended by FDA, or court ordered to take over their duties. (See The QA Pharm 9/25/10.) Continue reading

Some Pharma People Love Fighting Fires

I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late to pull the proverbial baby out of the fire.  They are known as having a “can do” “go-get-’em” attitude, and nothing gets in their way to get the job done. This is their life day-after-day. They receive great praise for their selfless commitment to the company by doing whatever it takes to fix a situation, and to (usually) muscle the batch of product out the door. Continue reading

Business Process vs. Compliance Process: What’s the Difference?

Having recently flitted about on several of our finest air carriers across several continents, I have thought about how certain practices by the flight attendants are predictably consistent, and others vary.  For example, we’re always told to turn off our electronic devices at the point when the airplane doors are closed.  However, when it is time to hand out the pre-landing buttery mint, some flight attendants express their individuality with more flair than others. Continue reading

How to Lead Your Organization Out of a Consent Decree Crisis

It’s a most unfortunate tragedy that the approach taken by many when addressing underlying CGMP compliance issues is effectively based in a checklist mentality—a “To Do List.”  To be sure, solving fundamental regulatory compliance problems involves tactical work that is broken down into discrete executable steps. However, I become more convinced every day that the most significant challenges in life—regulatory, or otherwise—are more about “being” than “doing.” Continue reading