Showing items tagged as Training

  • 2020-bl-manufacturing-excellence-06_132x132

    GxP Training Redefined?

    To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.

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    Future Trends and Opportunities in Quality Assurance

    At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.

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  • 2020-bl-using-connected-quality_132x132

    What Connected Quality Means for Training

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

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    Creating a Lean Culture of Continuous Improvement

    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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  • 2018-bl-thumb-gxp-lifeline-quality-manager

    February Tip: Continuous Employee Training Reduces Deviations and Nonconformances

    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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  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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    GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    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!”

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

    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.

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  • Five Reasons Why TMF Training is Important

    Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year. If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready.

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  • Cleanroom Compliance: How to Address Common Challenges in Document Control

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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    Training Effectiveness – A Quality by Design Approach

    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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  • Data Integrity Starts With User Access

    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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  • American Laboratories Begins Phase II of 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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  • Vendor-Created End-User Training: A Lifeline or Just Enough Rope to Hang?

    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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  • What’s in Your Training Toolkit?

    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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  • When Good Teams Go Wrong

    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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    Retraining Employees: When Once is Not Enough

    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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