GxP Lifeline

 

  • How to Confuse and Confound Your Trainees in 10 Easy Steps!

    23 December, 2013 Jill Drummond, Director Training Education, Blood Systems

    On-the-job training is usually conducted one-on-one or in small groups so it can be challenging to confuse trainees; but fear not — when employees start a new job, they are usually a little nervous or apprehensive.  They want to make a good impression and they want to be successful in learning their new tasks.  This is when they are most vulnerable and they are easy pickings for total confusion.  Follow these simple steps and you will have your new hires running for the hills and

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  • An Argument for Effective Quality Management Systems

    31 December, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

    All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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  • Digging up Root Cause

    23 January, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.

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  • Establishing a Master Harms List: Streamlining Risk Management

    24 January, 2014 David Amor, CQA, MS Managing Partner, MEDgineering

    Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs - whether from other hazard analyses, customer complaints, instructions for use or otherwise - the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources.

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  • How Dole Uses Technology and Proactive Food Safety Program To Save Time, Money

    27 January, 2014 Nye Joell Hardy, Senior Food Safety Manager, Dole Fresh Vegetables

    This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.

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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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  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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  • MasterControl's Murray & Knauer Guest Speakers at MD&M West

    5 February, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week. MD&M West is the world’s largest medical OEM event.

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  • Collaboration is More Than Just a Buzzword in Regulated Environments

    10 February, 2014 Marty Jackson, Professional Services Consultant, MasterControl Inc.

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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  • “3 Loops in 1” as Reflected in FDA Warning Letters

    12 February, 2014 Cindy Fazzi, Marketing Communications, MasterControl Inc.

    Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

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  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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  • Medical Device Clinical Trials – How Do They Compare with Drug Trials?

    18 February, 2014 Brandy Chittester, Director of Clinical Monitoring Services, IMARC Research, Inc.

    It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!

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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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  • Beyond Writing It Down

    19 February, 2014 by David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

    “If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.

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  • What Does the New FDA Guidance on Electronic Submissions Mean?

    25 February, 2014 by Cindy Fazzi, Marketing Communications, MasterControl Inc.

    Two years after the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, the FDA has taken a step forward in requiring electronic submissions under FDASIA. Do you know how this new requirement is going to affect your submissions?

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  • Quality Event Management: Free Recorded Webinar Shows How a Closed-loop Methodology Can Improve CAPA Systems

    27 February, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Quality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!

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  • Be SMART: 5 Critical Factors in CAPA

    4 March, 2014 by Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.

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  • More Helpful Quality Event Management Tips from MasterControl CAPA Presentation

    5 March, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.

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  • Food Safety is a Matter of Degree

    7 March, 2014 by Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    Global Food Safety Conference 2014 kicked off recently in Anaheim, California with a record-breaking attendance. It seems that everyone is concerned about the condition of the food they eat, if they have it to eat.

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  • Four Team Members to Include When Building Your Software Implementation Dream Team (and Two to Avoid)

    11 March, 2014 by Stephanie Jones, Professional Services Consultant, MasterControl Inc.

    According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abando

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