• FDA Inspections: Be Prepared to Ensure Quality and Compliance

    12 November, 2013 Michael R. Hamrell, Ph.D., RAC, FRAPs, CCRA, RQAP-GCP, MORIAH Consultants

    You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions. Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit. However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

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  • A Risk-Based Approach to Validation

    10 December, 2013 Peter Knauer, Partner Consultant, MasterControl Inc.

    FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:

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  • 10 Guidelines for Writing Superior SOPs

    18 December, 2013 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value.  Using the following 10 guidelines, you can create a successful SOP document.

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  • 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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  • 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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  • 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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  • Sound Risk-Based Decision Making in Process Validation

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

    There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “

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  • An Introduction to Metrics Collection and Usage

    20 March, 2014 by Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

    Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.

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  • 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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  • 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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  • 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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