• Quality Misconceptions

    4 January, 2011 Jennifer Stepniowski, Special Project Manager, Pro QC International

    For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

    Full story
  • Recent ASQ Survey Finds Companies Dissatisfied with BPOs

    7 December, 2010 MasterControl

    Many companies seek the expertise of BPOs. Business Process Outsourcers have, in many cases, shown that the BPO model can save companies significant expense. However, a recent survey conducted by ASQ shows that those company representative respondents aren't expressing the satisfaction they'd like to express in their respective BPOs.

    Full story
  • Med-tech Firms Face a Changing Economic, Regulatory Landscape

    6 December, 2010 Janet Moore, Minneapolis Star Tribune

    This article was first published in the Minneapolis Star Tribune on October 20, 2010.

    Full story
  • 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

    Full story
  • Change Control - Continuous Quality Improvement in FDA and ISO Environments

    15 November, 2010 Jason Clegg, Marketing Director, MasterControl, Inc.

    Globalization of the marketplace has greatly intensified competition and has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.

    Full story
  • Device Makers Can Use New FDA Database

    7 November, 2010 MasterControl

    There is one thing that every device manufacturer knows: it can be very difficult to effectively manage and support suppliers.

    Full story
  • What Does 'Readily Available' Mean?

    7 November, 2010 MasterControl

    If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.

    Full story
  • Assessing the Proposed Changes to the US FDA's 510(k) Programme

    6 November, 2010 Karen M. Becker, PhD, Founder and Chief Executive Officer of Becker & Associates Consulting, Inc.

    Note: This article originally appeared in the September-October issue of Regulatory Affairs Medtech, and was published online at www.regulatoryaffairsmedtech.com on September 8, 2010.

    Full story
  • ISO Standards: Quality Objectives and Quality Dreams

    6 October, 2010 Mark Kaganov, Director of Quality Operations, Quality Works

    Author's Note: This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives

    Full story
  • Supplier Evaluations Differ from Audits in Scope - Did You Know?

    6 October, 2010 MasterControl

    EduQuest, a global team of compliance experts, recently answered a query regarding supplier evaluations and audits. You might find this to be of interest to your company as well!

    Full story
  • Did you know that a newly issued final rule will affect Pharmaceutical and Biologics clinical trials?

    6 October, 2010 MasterControl

    For Pharmaceutical and Biologics companies that organize or participate in clinical trials, final rules issued by the FDA can have a significant impact on policies and procedures related to the implementation of a clinical trial. A recently issued final rule addresses how and when safety information must be reported.

    Full story
  • Computer System Validation: FDA Inspections

    6 October, 2010 Michael J. Gregor, President, Compliance Gurus, Inc.

    Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. A

    Full story
  • Defining GxP Training / Learning: Part 1

    6 October, 2010 Nancie E. Celini, GxP, Learning Program Lead

    The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

    Full story
  • FDA Device Reclassification Could Save Industry Millions

    6 October, 2010 MasterControl

    All medical device manufacturers know the implications of the Class I, II and III device categories. If a device falls in the Class I category then the probable mantra is "Full steam ahead! Piece of cake!" Perhaps this "mantra" seems exaggerated but in comparison to Class II stipulations, Class I requirements do seem relatively simple.

    Full story
  • Compliance Issues with 21 CFR Part 11 Standards

    6 October, 2010 MasterControl

    The inspections are due to occur "soon" according to an announcement made by FDANews and the inspections are expected to lead to 1) additional guidance, 2) an amendment(s) to the Part 11 regulatory text, or 3) both.

    Full story
  • How Auditing Supports Supply Chain Management

    6 October, 2010 Dennis R. Arter, FASQ, CQA

    There are four parts of supply-chain management:

    Full story
  • Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program - Part 2

    6 October, 2010 Nancie E. Celini, GxP, Learning Program Lead

    In the previous article I discussed the use of the acronym "GxP" as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.

    Full story
  • Quality Basics Simplify Complex Engineering Document Management Challenge

    6 October, 2010 Ted Shaar, Freelance Writer on Quality Topics

    This article was originally published in ASQ.

    Full story
  • Conducting a Clinical Trial in Europe from the Perspective of a U.S. Virtual Company

    10 September, 2010 Dr. John McLane, VP Clinical and Regulatory & COO, Clinquest

    A common biotech business model is to have a lean and fast virtual organization. These organizations are established with experienced professionals who have a wide breadth of entrepreneurial experience and experience within the pharmaceutical, biotechnology or even medical device sectors. These organizations also have innovative products that are to be developed to the next inflection point, which is usually a step to reduce further developmental risk. The product can then be moved on toward r

    Full story
  • Did you know that in 2011 the FDA is going to be targeting Part 11 compliance more closely?

    10 September, 2010 MasterControl

    Why target adherence to Part 11 requirements?

    Full story