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Showing items tagged as Quality

  • Quality Problems: Beyond Root Causes to 'Real Causes'

    8 May, 2018 by David Manalan, Principal, INQC Consulting

    Root cause analysis and corrective actions plans work well for solving quality problems, but how do you prevent quality incidences altogether? You have to dig deeper and investigate what David Manalan dubs the "real root cause."

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  • Why Fraud Control Plans Are Completely Unnecessary

    3 May, 2018 by Rod Farrar, Director, Paladin Risk Management Services

    With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.

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  • How to Minimize Protocol Deviations

    1 May, 2018 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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  • Top 5 Up-and-Coming Trends for Nutraceuticals in 2018

    10 April, 2018 by Sarah Beale, Staff Writer, MasterControl

    Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. The industry has expanded its focus to not just provide natural, clean products but also innovative, high-quality ones. The five biggest trends for 2018 reflect this, bringing new steps and creativity to the product development process.

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  • Complaint Analysis: Don’t Forget the Work You’ve Already Done

    5 April, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.

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  • GDPR Deadline Approaches: What Is Expected for Compliance?

    3 April, 2018 by Dave Jensen, Staff Writer, MasterControl

    First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

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  • Top 10 Takeaways from MD&M West 2018

    15 March, 2018 by David Jensen, Staff Writer, MasterControl

    I recently attended the 2018 MD&M West conference, Feb. 5 – 7, in Anaheim, California. The three-day event pulled together the medical device industry’s top engineering, design and regulatory compliance experts. This year’s conference covered the most timely and pressing topics, including technology, cybersecurity, design control, digital health and regulatory updates.

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  • What, No Installation Records?

    27 February, 2018 by Christopher Joseph Devine, Ph.D., President, Devine Guidance International

    Christopher J. Devine delves into the topic of medical device installation recordkeeping, and why proper documentation of this process is essential to successfully installing medtech and avoiding warning letters and other mishaps.

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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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  • January Tip: Strategies for New Regulatory Managers

    30 January, 2018 by Patricia Santos-Serrao

    A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.

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  • January Tip: How to Choose and Use External Consultants

    23 January, 2018 by Jake Walton, Quality Manager

    External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.

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  • Ensuring Quality In Medical Device Trials

    11 January, 2018 by Mary Lewis, Senior Clinical Research Specialist, IMARC

    Manufacturers have used a quality systems approach to ensure consistency within their processes for years, but the FDA is now encouraging clinical researchers to take a similar approach to medical device trials.

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  • The Quality Leader's Guide to Quality 4.0

    12 December, 2017 by Beth Pedersen, Staff Writer, MasterControl

    As a new calendar year approaches, the technology at our disposal is exceeded only by the number of ways it can be applied to improve communication, understanding, planning and productivity. In fact, the last decade has seen such rapid advances in areas like connectivity, mobility, analytics, scalability and data that it has sparked a fourth industrial revolution, known as Industry 4.0. IT and operations teams are chomping at the bit to implement these new technologies to help them operate better, smarter and faster. But what does this mean for quality and the teams responsible for it?

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  • What Is Pharmaceutical Quality by Design?

    9 November, 2017 by Beth Pedersen, Staff Writer, MasterControl

    It seems that Quality by Test is well on its way to being a thing of the past, and for good reason. With only one out of every 10 drug products actually making it to market, it is no surprise that pharma companies are increasingly eager to adopt measures to ensure quality and manage risk. Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits.

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  • QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?

    26 October, 2017 by Kimberlee A. Washburn, Regulatory Affairs Author

    In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

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  • How to Become a QP in Europe

    24 October, 2017 by Wolfgang Schmitt, Director Operations. Concept Heidelberg

    Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

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  • Three Ways to Accelerate Your Lean Journey

    4 October, 2017 by Dan Markovitz, Founder, Markovitz Consulting

    I spent two days in St. Louis last week at the Global Lean Leadership Conference. It’s a small conference—only about 150 people—consisting of companies that have embraced Paul Akers’s 2 Second Lean philosophy. Companies that wanted to join the conference were required to have the president attend (although there were many other people from those companies as well).

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  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 by Stephanie Gaulding, CQA, CPGP, DPS Engineering

    I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

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