Nov 29, 2016

GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

 Organizations overlook benefits that 
can be achieved by applying the same tools 
and methods in the clinical space that they 
are already using for quality management.  

by Patricia Santos-Serrao

Global Pharmaceutical, Blood & Biologics Segment Manager


In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

The worlds of clinical and quality share the same collision anxiety. Many companies mistakenly believe that quality and clinical are completely separate departments that should maintain their data and processes in discrete silos. What these organizations are overlooking are the benefits that can be achieved by applying the same tools and methods in the clinical space that they are already using for quality management.  

Nov 22, 2016

Process Validation Habits You Should Quit Cold Turkey

IQ/OQ/PQ is for the birds. 
So why are you still using it?

by Lisa Weeks,
Marketing Communications,

It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.
As to its origin, there are many theories out there. Some think the phrase evolved from the older idiom “talking turkey,” which means to speak frankly and directly. Others note the similarities between the physical changes a person goes through as part of the withdrawal process that can leave him or her looking clammy, pale and, well, like a cold turkey (minus the stuffing and cranberry sauce). Everyone seems to agree that “quitting cold turkey” is a pretty unpleasant experience. It also tends to have a lower success rate than the slow and steady approach. So why do we do it? Is the cold turkey technique ever a good option (as opposed to the leftover cold turkey sandwich, which is always a good option)?

Nov 17, 2016

5 Lessons Quality Pros Can Learn from Brad Pitt and Angelina Jolie’s Split

Breaking up is hard to do but so is 
sticking with an inefficient or outdated 
quality management system.

by Lisa Weeks

Marketing Communications Specialist


The Brangelina uncoupling has made headlines around the world—and not just in the tabloids and entertainment publications. “How Will Angie and Brad Split their Real Estate?” asks Realtor.com. A recent Forbes article explains, “What You Can Learn About Divorce & Taxes from Brad Pitt & Angelina Jolie.” Legal blogs are going crazy with posts about prenups; they’re not just for the rich and famous, you know. Yes, the Bradexit is much bigger than the Britexit. It seems like all of us can learn something from their breakup—even those of us who work in the quality industry.

Nov 15, 2016

Process Validation: Life Cycle Approach Beats Crossing Your Fingers

Knocking on wood is not 
effective process validation

by David Jensen

Marketing Communications


“Repetition does not transform a lie into truth.” – Franklin D. Roosevelt

If you do something right three times, you should be able to do it that way always. If this is your approach to process validation, Hal Baseman, chief operations officer at ValSource LLC, begs to differ. Baseman shared some insights about improving process validation at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14. 

Nov 10, 2016

Optimizing Outsourcing Options for Small Sponsors

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc.

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partnerships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements. 

Nov 8, 2016

Factoring Regulatory Strategy into New Product Development

Avoid brick walls by incorporating a
Regulatory Assessment at the beginning 
of new product development.

by Kimberlee Washburn

Regulatory Compliance Associates

The Importance of an Upfront Regulatory Strategy

It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.  

The best way to avoid this problem is to put into place a “Regulatory Strategy” or “Regulatory Assessment” document during your first design control stage.  Some companies may choose to call this document the “Regulatory Strategy” and others prefer the term “Regulatory Assessment”, but for simplicity, I will refer to this as the “Regulatory Assessment” in this article.  The Regulatory Assessment will house all of the regulatory planning information for the new medical device, or the “upgraded” or “modified” device that incorporates design changes.   

Nov 7, 2016

Free E-Book: 5 Things to Expect in the Future of Regulatory Compliance

by Cindy Fazzi

Editor, MasterControl Insider

Global health care spending is expected to increase by 4.3 percent until 2019, with biotech drug sales and medical device revenues forecasted to reach $445 billion and $454 billion, respectively, in 2019 (1). Given such growth, what kind of regulatory landscape can you expect? A newly released enhanced e-book offers five forecasts.

Matt Lowe, a mechanical engineer and medical device industry veteran, describes what the future would look like in terms of compliance for life science companies in his debut book, “Convergence of Compliance and Technology.” He also shares compelling anecdotes about the struggles of regulated companies and traces the major developments that transformed the compliance process in the past decade.

Nov 3, 2016

How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

by Jon Beckstrand


MasterControl Inc.

Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.

While doing research on the history of Good Manufacturing Practices (GMP) for a presentation I made, I came across the extraordinary story of Kelsey, who helped avert a medical disaster in the United States in the 1960s. On her second month on the job at the FDA, Kelsey reviewed the new drug application (NDA) for thalidomide, a sleeping pill widely used in Europe for morning sickness. It was supposed to be an “easy” assignment suitable for a rookie like Kelsey because the drug had been in the market overseas since 1957.

Nov 2, 2016

Retraining and Refresher Training: Aren’t They One in the Same?

What gap are you trying to solve 
with retraining and refresher training?

by Vivian Bringslimark

HPIS Consulting, Inc.

I say no, not at all.  Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS.  He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time.  It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.