Oct 23, 2014

From Good to Great – the One Skill Great CRAs Possess

From Good to Great – the One Skill Great CRAs Possess
To be a great CRA, one skill is needed:  active listening.
by Holly Deiaco-Smith, MS

What skill differentiates a good clinical research associate (CRA) from a great CRA?

a.  Knowledge of clinical processes and the regulations that govern them?
b.  Ability to be flexible with travel and work schedules?
c.  Ability to spot errors that could gravely impact data and ultimately patient safety?
d.  A relentless zeal for ensuring assigned sites are “buttoned up?”

The answer- none of the above. 

Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

Oct 21, 2014

Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach



Dahl Compliance Consulting

Now more than ever, pharmaceutical companies must not only have an effective corporate compliance program in place, but senior management and boards of directors at these companies must ensure that they evaluate the effectiveness of those programs.  The best reason to evaluate the effectiveness of your compliance program is so that you know whether or not the program is managing the particular risks facing your company.  If you are responsible for protecting your company from risk, shouldn’t you want to know that your compliance program is working?

Oct 16, 2014

Why Food Makers Are Investing In Food-Safety Software

Why Food Makers Are Investing In Food-Safety Software
by Sam Lewis
Associate Editor, Food Online

Throughout 2014, food makers have put forth significant efforts in pursuit of food-safety and quality-management software solutions. But why is there so much interest and effort in these systems now?

The Obstacle Of Paperwork

To put it bluntly, handling paperwork is a burden that creates more problems than it solves. A misplaced invoice, a forgotten signature, an accidentally destroyed document… all of these scenarios can wreak havoc on a quality-manager's workload. Not to mention the bottleneck it creates on workflow. Developments in supply-chain management, fraud prevention, and food safety are only extending and complicating the labors of safety officers. Fortunately, software solutions and automated processes are able to take on these added tasks and ease the minds of safety and quality-assurance workers.

Oct 14, 2014

FDA vs. EU Inspections: Similarities & Differences

IPRF, LLC – RA/QA Consulting & International Product Registration

EU-FDA Joint Initiative

The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

These joint GCP inspections come under an arrangement between the European Commission, the European Medicines Agency (EMA), and the FDA. The initiative allows them to streamline the sharing of information on inspection and observations and facilitates the conduct of collaborative inspections. The goal is for European Union (EU) inspectors and FDA inspectors to have the same information about a facility. 

Oct 7, 2014

INFOGRAPHIC: U.S. Manufacturing Facts and Figures

by David R. Butcher, Marketing Communications, MasterControl

Last Friday marked the third annual Manufacturing Day (MFG DAY), a growing grassroots movement of manufacturers dedicated to bringing attention to modern North American manufacturing and empowering the professionals who compose it. Here we highlight some of the contributions of U.S. manufacturers to the nation’s economy.

Since 2012, manufacturers all across the United States, U.S. territories and Canada have opened their doors to the public on the first Friday of October, and often throughout the month. Organized by the Fabricators & Manufacturers Association (FMA), the National Association of Manufacturers (NAM) and the National Institute of Standards & Technology’s (NIST) Manufacturing Extension Partnership (MEP), MFG DAY is designed to highlight new technologies and innovations, address common misperceptions about the sector and inspire the next generation of manufacturing professionals.

Oct 2, 2014

The 3 Biggest Project Management Problems in the Regulated Environment


Lead, Solutions Consultants Group, MasterControl Inc.

Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Health, Labour and Welfare (MHLW) in Japan expect companies under their jurisdictions to have a formal project management plan that addresses relevant requirements, design control, and change control, among other things.

Sep 30, 2014

5 Tech Support Life Hacks for Better (and Fewer) Support Calls


5 Tech Support Life Hacks for Better (and Fewer) Support Calls
Calling tech support doesn't have to 
ruin your day. Really.
by Eric Weeks 
Technical Account Manager, MasterControl


Life hacks, which are practical tips or shortcuts that help you get things done faster and more efficiently, are all the rage these days.  A quick Google search reveals hacks for overcoming many of life’s pesky obstacles or frustrations—from how to keep a pot of water from boiling over (place a wooden spoon across the top it) to how to light a candle wick without burning  your fingers (use a dried spaghetti noodle).

For some users, calling tech support is considered to be one of those hack-worthy frustrations.  With this in mind, I’d like to suggest some handy hacks to make your interactions with tech support, whether you’re calling about software, hardware, or technology in general, smooth and less stressful. They may help you avoid having to call at all. 

Sep 25, 2014

Understanding the Relationship between GMPs and Adulteration

GMPs are policy goals that do not specify how an 
activity is done, just the result it should achieve. 
The name  also lacks any link back to the overarching 
purpose of the practices.

by Marc C. Sanchez
Contract In-House Counsel & Consultants, LLC  

Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers. In truth GMPs are policy goals that do not specify how an activity is done, just the result it should achieve. The name also lacks any link back to the overarching purpose of the practices. GMPs are not a scoring or rating system. Instead GMPs are a crucial link to avoiding adulteration and ensuring quality. The practices set a floor or safety net of minimum facility sanitation practices to ensure cosmetics are not indirectly contaminated. It also establishes a consistency that secures quality. GMPs are oft cited by the FDA following facility inspections in Form 483s and Warning Letters because it provides a window into the culture and compliance mindset of a facility. That mindset suggests the likelihood of adulteration or larger compliance violations. 

Sep 23, 2014

Why Do Corrective Actions Fail?

Why Do Corrective Actions Fail?
There are two fundamental reasons why 
most corrective actions  programs fail.
by Ed Grounds, President
Integrated Solution Providers Software, Inc.

Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?”  Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing.   Normally, we turn the question back around to the group and ask them why they think their corrective action program fails.  The most common answers we hear are:  limited time, resources, training, or not knowing which tools to use.

Sep 18, 2014

The Nine Elements of Lean Configuration



The Nine Elements of Lean Configuration
Nine elements comprise the Theory of Lean Documents
by José Ignacio Mora, Owner, 
Atzari Enterprises, L.L.C.

The allure of finally terminating your paper quality management system (QMS) feels very liberating. You can see the excitement in everyone's eyes during the new QMS software presentation.  Gone will be the days of paper engineering change notice---everything will be circulated and approved electronically and finally everyone will have time to do their jobs. They can hardly wait to tell their cubicle buddies about the new world they will soon live in.

Nine months later into the three-month project ...

Sep 16, 2014

Communicating Priorities to Your Employees

SVP, Marketing
MasterControl Inc.

Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

Sep 11, 2014

INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction



by David R. Butcher, Marketing Communications, MasterControl

In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.