• Creating a Lean Culture of Continuous Improvement

    22 March, 2018 by Jared Evans, Professional Instructor and Lean Process Coach, MasterControl

    When working on my bachelor’s degree, I had a memorable experience in a creativity and problem-solving course. In order to calm the growling of our starving student stomachs, the professor said he would reward us with a treat when we turned in our completed homework assignment at the next class period.

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  • February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    9 February, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .

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  • Future Trends and Opportunities in Quality Assurance

    19 October, 2017 by David Jensen, Staff Writer, MasterControl

    It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

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  • Retraining Employees: When Once is Not Enough

    1 January, 2008 by Lynn A Emmert, M.Ed., MT(ASCP)SI

    Most supervisors would agree that their staff wants to do a good job and that their employees do their best to meet the demands of the highly regulated blood bank industry. But occasionally management has to deal with employee performance that falls short of expectations.

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  • Implementing a New System: Why Training Reinforcement is Critical

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.

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  • 100% Training Complete ≠ 100% Effectively Trained

    31 January, 2013 Vivian Bringslimark, President HPIS Consulting, Inc.

    "Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness.

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  • When Good Teams Go Wrong

    17 July, 2012 by Ruth Dubinsky, MS, President, Clarity Consulting

    How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members?

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  • Defining GxP Training / Learning: Part 1

    6 October, 2010 Nancie E. Celini, GxP, Learning Program Lead

    The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

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  • What’s in Your Training Toolkit?

    29 January, 2014 David Hofstetter, Manager, Learning and Development at New England Organ Bank

    Do we do a good enough job at identifying the real issue or are we in such a hurry to meet a requested deadline that we simply take the word of the requestor? How do we know we are truly solving the issue and not just meeting a request? 

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  • Vendor-Created End-User Training: A Lifeline or Just Enough Rope to Hang?

    19 February, 2014 Donna Bailey, Instructional Design Specialist, MasterControl Inc.

    So you’ve implemented a new software system, and you’re supposed to go live with it in four weeks. It has taken you months to get to where you are: months bordering on a year. You’ve had to let some of your normal job responsibilities slide because of how much time this implementation is taking, but it can’t be much longer, right? You go through your checklist: Is the system configured the way you need it to be for your company? Check; or at least you think so. Are your documents imported and easy to find? Check; well, you can find them, but you honestly don’t know how your end users will find them. Do you have a support group at both your company and the software provider on the ready? Check; kind of. The people in your group went through the same training as you did so that means they know at least as much as you do, and you have a business card from the software trainer and the number for tech support if something goes wrong. Have you developed and distributed the end-user training? Hmmmm, no. Well, that can’t be too hard, right? Just take a couple of screenshots, write some steps, and bang—you have end-user training.

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  • Happy Employees Matter

    1 July, 2014 by Curt Porritt, Senior Vice President Marketing, MasterControl Inc.

    Every year, Fortune Magazine publishes a list of the top 100 companies to work for. These companies are well known for how well they treat their employees. In 2005, Deloitte Consulting decided to see if there was a correlation between a positive work environment and corporate success. They tracked the shareholder returns of the 56 publicly traded companies on Fortune’s 2005 list of best companies to work for. According to this study, these companies not only consistently beat the S&P 500, but “walloped it.” Companies that have happy employees apparently have a better chance of success than those who don’t. As Deloitte principle Bob Dalton explained, “This puts real data on something that seems intuitively true.” *

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  • Communicating Priorities to Your Employees

    16 September, 2014 Curt Porritt, 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.

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

    30 September, 2014 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).

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  • American Laboratories Begins Phase II of MasterControl

    12 November, 2014 MasterControl

    American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

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  • 7 Document Management Blunders that Jeopardize Compliance

    25 February, 2015 James Jardine, Marketing Communications, MasterControl

    Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

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  • Four Reasons to Automate SOP Management in FDA and ISO Environments

    26 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

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  • Data Integrity Starts With User Access

    10 March, 2015 Jamie Colgin, Colgin Consulting

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

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

    21 May, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    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.

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  • 7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

    18 May, 2018 Ginette Colazzo, President, Ginette M. Collazo Human Reliability Consultancy

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

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  • Training Effectiveness – A Quality by Design Approach

    5 November, 2015 Holly DeIaco-Smith, MS, HDS Consulting

    In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.

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