May 21, 2015

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here! 
What's an SOP?"
by Laurie Meehan
Social Media ManagerPolaris Compliance Consultants

“What tipped you off?”
“How did you know to look there?”

When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel. Really. No kidding. Pinky swear. The audit findings, not surprisingly, are real too. I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations.

May 19, 2015

Cosmeceuticals: the Good, the Bad and the Ugly

What is a cosmeceutical?  Is it a lotion, 
a shampoo, shaving cream? 
Or is it something else?

By William L. Schwemer

Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.”  I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together.  At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them.  To get started I searched the Internet to see what others were saying about these products.

May 14, 2015

The Bright Future of Quality and Compliance

Executive Vice President, Operations

Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?

Only three decades ago, all business computing capability resided in the hands of programming and IT specialists. If you needed any computational or data power to perform your business function, you were referred to the computer department. They queued your request and later dispensed the results—a report or an analysis. The methods and tools of their craft remained mysterious to most. Yet their expertise in the arcane enabled the critical functions of business.

May 12, 2015

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

When quality and compliance are incorporated into 
operational excellence strategies, companies are able
 to thrive in the competitive life sciences marketplace. 

by James Jardine

Marketing Communications, MasterControl

Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties. 

You can download a free copy of the eBook here.

The eBook highlights a variety of timely topics, including:
  • the pressures placed on life sciences companies by the cGMP regulations set forth by regulatory bodies like the FDA 
  • the benefits of “holistic” quality management 
  • some examples of leading organizations’ approaches to quality challenges 
  • data demonstrating the effectiveness of electronic quality management 
  • systems recommendations for improving quality going forward

May 7, 2015

A Business Case for Engendering Trust in Your Company

Building and maintaining organizational 
and market trust can yield great 
dividends for companies.

by Kevin Ash
Senior VP of Services, MasterControl

In the 2015 Edelman Trust Barometer, an annual trust and credibility study, the world’s largest public relations firm found that people’s trust levels in business fell in 16 of the 27 countries surveyed. The findings revealed that the people’s trust in business declined in two-thirds of the markets and now sits below 50 percent in the majority of countries – the worst showing since 2008.

Although the once-impenetrable technology industry remains the most trusted of all industry sectors (at 78 percent), declines across all tech-based industries were visible in the latest findings.

Needless to say, this widespread disintegration of trust is troubling for business.

May 6, 2015

The ISO 9001:2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.  
Prepare to jump on this change train!
by Robyn Barnes
Marketing Communications, MasterControl

ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

Once the standard is published, companies will have a three-year transition period within which to comply.  Managers and other professionals involved in implementing, maintaining and auditing quality management systems are encouraged to be proactive and think about what they can begin doing now to achieve compliance with the revised standard.

May 5, 2015

Creating a High Performance and Low Risk Work Culture

The best articulated corporate vision and strategy 
is of no value if it cannot engage the hearts, minds 
and work habits of employees at all levels 
and convey a purpose beyond just profit. 
by David J. Patrishkoff
President, E3

Most of us have heard the phrase: "Culture eats strategy for breakfast." It could also be restated as "Your actions speak louder than your words." This means that management can dream up any strategy they want to but their behaviors and actions are what creates the culture of an organization, not their strategy. Culture drives the efficiency of an organization's processes. The culture drives the success or failure of an organization. The culture is the product of leadership decisions or the lack of decisions.

The mix of positive and negative forces present in any work culture fuels the cascades that drives success or failure of the whole organization. The best articulated corporate vision and strategy is of no value if it cannot engage the hearts, minds and work habits of employees at all levels and convey a purpose beyond just profit. 

Apr 29, 2015

Top 5 Medical Device Trends That Will Dominate 2015

Learn how to navigate the biggest industry trends of 2015.  

by Lisa Weeks

Marketing Communications, MasterControl

More connected and consumer-driven than ever before, the medical device industry is in the middle of a truly transformative year. Three-dimensional printing, mobile health apps, and other disruptive technologies are changing the way providers deliver care and prompting regulators to re-examine their roles. Consumers are demanding more transparency and convenience but are also concerned about the security of their medical information. Investors and stakeholders are paying closer attention to reimbursement policy, which could limit innovation and access to life-saving products. In the midst of it all, regulatory frameworks in Europe and the U.S. are undergoing massive changes. Here are five trends worth watching this year.

Cut through the Clutter: Simplifying Regulatory Compliance

Cut through regulatory red tape to improve
quality, compliance and time to market.

by David R. Butcher, Marketing Communications, MasterControl

For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market.

As highly regulated companies’ leaders look to bring their innovative products to market, many consider mounting regulatory pressure a key disruptive issue in their industries moving forward.

Apr 28, 2015

MasterControl Revs Up Improvement

by Craig Gygi
Executive VP Operations, MasterControl

The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and in every geography, companies have figured out that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

Apr 23, 2015

Risk: 2015’s Most Valuable Player?

In 2015, risk may become quality's most 
valuable player and could drive quality to a 
new level of proficiency.
by Marci Crane
Marketing Communications, MasterControl

For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

Chances are high that those reading this blog entry are beginning to see the emerging patterns of quality in their own organizations. Perhaps, even this early in the year, one area of quality already stands out more than others. There are certainly many improvements that can be made and when even one aspect of quality is improved it’s likely that new successes will present themselves organization-wide.

Apr 21, 2015

Fewer Donor Hearts Used

A new study tracked a pronounced decline in the 
use of donor hearts overall in the United States.
by Sheila Yu
dailyRx News

As the waiting list for heart transplants has grown longer, fewer hearts have become available for transplantation in the US in recent years.

A new study tracked a pronounced decline in the use of donor hearts overall in the US.

The authors of this study noted that some US regions used more donor hearts than others. As a result, they suggested the need for updated and standardized guidelines on donor heart use and acceptance.