Showing items tagged as Quality

  • Surviving Live Data Inspections by the FDA---3 Critical Success Factors

    19 January, 2017 B. Christine Park, CQA, CQM/OE Consultant

    I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection. Historically, you’d print the files for FDA review rather than do a live demonstration of the database information. While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review. Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.

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  • How to Lead with Respect

    7 February, 2017 Mike Orzen, Founder, Mike Orzen & Associates

    “Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”

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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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  • Quality Pros & the Oscars: Films to See Based on Your Personality

    16 February, 2017 Cindy Fazzi, Staff Writer, MasterControl

    It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

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  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

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  • Supplier Approval Challenges Under FSMA

    1 March, 2017 Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

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  • The Inner Game of Continuous Improvement

    14 March, 2017 by Jon Miller, Co-founder and Partner, Gemba Academy

    by Tim Gallwey for helping him overcome anxiety and self-doubt, and to keep winning. I read the book looking for parallels and general lessons that could be applied to workplace performance and continuous improvement, and was not disappointed. Here is a summary of what I learned about what I will call “the inner game of continuous improvement.”

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen, Staff Writer, MasterControl

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • 5 Warning Signs of Diminishing Supplier Quality

    30 March, 2017 David Butcher, Staff Writer, MasterControl

    supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager, MasterControl

    “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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  • What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

    20 April, 2017 by Bryan Armentrout , CEO, The Food Leadership Group

    Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 by Drew Locher, President, Change Management Associates

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • 10 Criteria to Aid in the Selection of Investigative Sites

    2 May, 2017 by Craig Morgan, Head of Marketing, goBalto

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

    16 May, 2017 by Maile Gradison Hermida and Brian D. Eyink, Hogan Lovells US LLP

    With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • When GCP & GMP Meet

    30 May, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

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