GxP Lifeline

 

  • Changing Supplier Controls Requirements

    26 March, 2014 by John E. Lincoln, J.E. Lincoln and Associates

    Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.

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  • MasterControl 's Ken Peterson and Patricia Santos-Serrao Featured SQA Speakers

    1 April, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.

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  • Making SMART Choices When Managing Quality Events: More Helpful CAPA Tips

    2 April, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.

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  • Demystifying FDA/CDRH Appeals Process

    3 April, 2014 by David Lim, President and Principal of Regulatory Doctor and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.

    We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.

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  • On the Quality of Vendor/Supplier Audit Responses

    8 April, 2014 by John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants; Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.

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  • Leverage TOQ for a Faster, Cost-Effective Software Validation

    10 April, 2014 by Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc.

    More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.

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  • Report from MD&M West Conference: Navigating through the PMA and 510(K) Submission Processes

    15 April, 2014 by Peter Knauer, Senior QCC Consultant, MasterControl Inc.

    I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conferen Trouble-Free Validation with MasterControl (1:38)ce. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

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  • Change Control and Its Role in Continuous Quality Improvement

    17 April, 2014 by Lisa Weeks, Marketing Communications, MasterControl Inc.

    The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and more importantly, being able to control it, is critical to maintaining compliance. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?

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  • Principles of Lean Documents

    22 April, 2014 by José Ignacio Mora, Owner, Atzari Enterprises, L.L.C.

    Many would chuckle at this story as a simplistic analogy.  Yet, there are many lessons from this example that could apply to a medical device facility.  No, it’s not a controlled document in the sense most understand it.  But the owner would not want it to be this morning’s breakfast menu during dinner, or to display last year’s prices.  Nor would she want it to show meal options that are not available.

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  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.

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  • Quality Beliefs Determine Behavior

    29 April, 2014 by Craig Gygi, Executive Vice President Operations, MasterControl Inc.

    A few years back, I helped an international holding company assess the operations of their portfolio of companies. They wanted to know things like, “How Lean is the operation at each company?” “How far along is each company in its Six Sigma improvement journey?” And “What are the common opportunities and strengths we can build upon?” I visited company sites, reviewed operation activities, collected data, and interviewed executives and staff. I found that in many ways, the foundation for excellence in operations can be boiled down to a single, simple question: “How do you define quality?”

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  • How Do I Follow The Trail?

    1 May, 2014 by Jamie Colgin, President, Colgin Consulting, Inc.

    One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.

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  • Six Easy Criteria for Targeting a Good Process

    6 May, 2014 Jason Piatt, President, Praestar-Consulting

    Whether we’re practicing Lean or Six Sigma, what we’re really targeting is process improvement. The process could be technical, commercial, or a support-process to the standard order-to-delivery process within the context of our manufacturing environment. All too often, manufacturing executives mistake a sequence of activities to be a process. That’s simply not the case. So, what makes a good process? 

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  • Strategies for Addressing the Top 3 Quality Pains in a Regulated Environment

    8 May, 2014 by Paul Sanderson Lead, Solutions Consultants Group, MasterControl Inc.

    In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.

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  • Understanding European Declarations of Conformity or Incorporation

    13 May, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    In the wonderful world of medical device regulation, a manufacturer may find it easy to become confused with FDA rules.  When your product moves to the international market, there are new rules that must be followed to get your product to market. 

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  • The Top 6 Pains in DHF Management

    20 May, 2014 by Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.

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  • Ruined by Best Efforts

    22 May, 2014 by Craig Gygi, Executive Vice President, MasterControl Inc.

    When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

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  • How to Cut Your Document-Approval Cycle Time Using Escalation

    27 May, 2014 by Marty Jackson, Professional Services Consultant, MasterControl Inc.

    From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

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  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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  • Five Trends Transforming the Medical Device Industry in 2014

    5 June, 2014 by Lisa Weeks, Marketing Communications, MasterControl Inc.

    Five Trends Transforming the Medical Device Industry in 2014

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