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Showing items tagged as quality management

  • 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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  • The Right EQMS for the Homeopathy Crackdown

    18 January, 2018 by Sarah Beale, Staff Writer

    For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.

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  • The Quality Leader's Guide to Quality 4.0

    12 December, 2017 by Beth Pedersen, Staff Writer

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

    26 October, 2017 by Kimberlee A. Washburn

    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

    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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  • Future Trends and Opportunities in Quality Assurance

    19 October, 2017 by David Jensen, Content Marketing Specialist

    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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  • Medical Device Firms: 3 Tips for Jumping Over the Dossier-Management Hurdle

    14 September, 2017 by Cindy Fazzi, Staff Writer

    For medical device companies, the ultimate goal is to commercialize their products, usually in more than one market. The road to a successful product launch in multiple markets is full of obstacles and one of the biggest hurdles is dossier management.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

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  • ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

    29 March, 2016 Greg Peckford Founder, Quality Career Advancement

    There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.

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  • ISO 13485:2016 What are the Changes About?

    3 March, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • 5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

    29 December, 2015 Lillian Erickson, Global Quality Manager, MasterControl Inc.

    The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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

    16 June, 2015 Ginette Colazzo, President of Ginette M. Collazo, Inc. 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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  • 5 Tips for Winning Executive Buy-In for a New QMS

    26 May, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

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  • A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

    12 May, 2015 ames Jardine, Marketing Communications, MasterControl

    Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties.

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  • 3 Keys to Driving Collaborative Growth in Life Sciences

    26 March, 2015 James Jardine, MasterControl

    A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.

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  • Closed-Loop Quality Management: Connecting the Value Chain

    24 March, 2015 James Jardine, Marketing Communication, MasterControl

    An increasing number of leading organizations are learning that quality management must extend far beyond the manufacturing environment, according to a recent eBook co-sponsored by LNS Research and MasterControl. The research collected in the eBook indicates that market leaders are beginning to implement a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service. Other findings in the book show that Enterprise Quality Management Software (EQMS) is vital to the establishment of an effective closed-loop system that can help a manufacturer better control costs, compliance, and risk.

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  • Five Steps to Building Process Efficiency with Your Supplier

    20 January, 2015 Stephen Gerald O’Neil, Consultant

    In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

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  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

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