• 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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  • 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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  • 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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  • “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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Avoiding the Silo Effect: The Importance of Communication in Clinical Trials

    12 November, 2013 Rebecca York, Senior Clinical Research Associate, PPD

    As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.

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  • Innovation and the Quality Process

    8 October, 2013 Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

    Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

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  • SOP Training is Now “On-Line” But Are We Any More Compliant?

    17 September, 2013 Vivian Bringslimark, President, HPIS Consulting, Inc.

    Well, I’m told we are now more compliant with ensuring that only the most current SOP version is used for training. And yes, our Learning Management System provides us with curricula updates and “percent complete” and “percent overdue” notifications. LMSes and eDoc systems have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job? Just look at our human error deviations and training-related CAPAs. Are the numbers declining? According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” (1) Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

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  • Ten Points for Successful Use of TPLC Reports

    8 October, 2013 Maria Fagan, President, Regulatory & Quality Solutions LLC

    A Total Product Life Cycle (TPLC) Program ensures that quality is proactively designed into medical devices from concept to market, and during post market surveillance until device obsolescence.

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  • MasterControl.Cloud

    5 September, 2013 Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions

    What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies.

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  • Process Validation for Medical Devices

    17 April, 2017 Dan O'Leary, President, Ombu Enterprises, LLC

    Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.

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  • Three Quality Management Tips to Avoid Death by CAPA - for Medical Devices Industry

    17 April, 2017 Ken Peterson

    It's been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal corrective and preventive action (CAPA) system to monitor and manage the safety complaints associated with their products. Yet, managing a CAPA system remains a major challenge for many manufacturers.A sound CAPA system organizes and evaluates complaints, nonconformances, and other deviations about products and services to improve patient safety. But the problem is: How do you

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  • Medical Device Firms Experiencing 'Death by CAPA?'

    1 March, 2008 MasterControl

    Eighty-eight percent of all Warning Letters issued by the FDA to medical device firms recently were related to CAPA deficiencies. Managing the CAPA process is a major challenge for most medical device companies. This problem can be so overwhelming that an FDA official called it "death by CAPA."Is your CAPA system helping or "killing" your organization? In the next issue, an article by Ken Peterson, senior partner of PathWise Inc., a leading CAPA training and consulting provider, will examine ris

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