• Biotechnology Article

    28 May, 2015 MasterControl

    The MasterControl quality management system is a flexible system since it can be constructed from a variety of individual quality control/quality assurance solutions.

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  • Transitioning from an FMEA Risk Analysis to a Total Risk Management System

    31 January, 2013 Richard Vincins, Vice President, Quality Assurance Consulting, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk

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  • Regulations Vary Worldwide but Risk Management is Common Demoninator

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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  • Uncertainty and Risk: Providing Value for Stakeholders

    10 July, 2013 Greg Hutchins, Principal Engineer, Quality + Engineering (Q+E)

    In Against the Gods: The Remarkable Story of Risk, the author says the mastery of risk is the foundation of modern life and is what divides modern from ancient times. By consciously or unconsciously calculating probabilities, auditors make intelligent decisions about business processes. First let’s look at a few definitions of risk.

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  • Why You Need to Go Beyond Risk Analysis

    30 October, 2012 Richard Vincins, Vice President of Quality Assurance, Emergo Group

    Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team itself identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk ass

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  • Ways to Ensure Supplier Compliance

    15 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Your suppliers are critical to your success. They can increase your company's efficiency-in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

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  • How to Build a Strong Supply Chain Team

    30 October, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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  • Managing Your Medical Device Suppliers

    12 June, 2013 Michelle Bonn, President, Expedient Trade LLC

    Since the medical device and drug industries have transitioned into global market players, the concept of “virtual manufacturing” has grown in popularity and necessity. What exactly is a virtual manufacturer? In the eyes of the FDA, virtual manufacturing applies to any medical device or drug company that outsources any of its manufacturing functions.  This includes, design, packaging, sterilization & regulatory functions.

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  • New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    10 August, 2013 Cathy L. Burgess, Donald E. Segal and Guillermo Cuevas,Alston & Bird LLP

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

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  • Single Sourcing of Critical Components: Strategies for Optimization

    28 November, 2012 Peter Knauer, Partner Consultant, MasterControl Quality and Compliance Advisory Services

    The increase in virtual or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the increasing reliance on single-sourced suppliers, particularly for critical components. While this can be an effective way to reduce the cost of goods and improve efficiencies, there are some significant risks associated with this practice. This article examines these risks and a

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  • Supplier Quality Agreements: Benefits to You and Your Supplier

    10 May, 2012 Betty Lane, Founder and President, Be Quality Associates, LLC

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc."

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  • 100% Training Complete ≠ 100% Effectively Trained

    31 January, 2013 Vivian Bringslimark, President HPIS Consulting, Inc.

    "Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness.

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  • Implementing a New System: Why Training Reinforcement is Critical

    17 July, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.

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  • Can You Use Automated Testing Tools as an FDA-Regulated Company?

    30 October, 2012 Janis Olson, Vice President of Quality and Regulatory Services, EduQuest, Inc.

    Can you use automated testing tools as an FDA-regulated company?

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  • Disaster Recovery and Validation

    12 June, 2013 Louis Rutledge, Manager of Services Development / Validation ServicesMasterControl Inc.

    Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs;

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  • The EMA 2012 Guidance for Process Validation

    19 February, 2013 Peter H. Calcott, Ph.D., President, Calcott Consulting LLC

    In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final versio

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  • Retraining Employees: When Once is Not Enough

    1 January, 2008 by Lynn A Emmert, M.Ed., MT(ASCP)SI

    Most supervisors would agree that their staff wants to do a good job and that their employees do their best to meet the demands of the highly regulated blood bank industry. But occasionally management has to deal with employee performance that falls short of expectations.

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  • The Use of "Poka Yoke" with Medical Device Design and Manufacturing

    17 May, 2011 by Jim Shore, Product and Process Improvement Leader, Dynisco

    The Poka Yoke method is something that improves your daily life; why not use it to make your product better, as well? The best solutions are simple, quick to implement and 100 times more effective than a 100-percent final inspection.

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  • Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) Program

    5 December, 2010 Claudette Kile, Principal Consultant, BMP Group

    Recently released recommendations for changes to the Food and Drug Administration's (FDA) 510(k) clearance program for class II medical devices has been a hot topic within the medical device industry. The 510(k) notification process uses predicate devices that the Center for Devices and Radiological Health (CDRH) at FDA has previously cleared for market release through the 510(k) notification process. New devices submitted for clearance must show substantial equivalence to predicate (cleared) de

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  • Quality Audit: Most Common Pitfall for Medical Device Firms

    17 April, 2017 MasterControl

    The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.

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