• 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

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  • 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.

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  • 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.

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  • 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.

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  • How Auditing Supports Supply Chain Management

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

    There are four parts of supply-chain management:

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  • 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.

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  • 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.

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  • 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

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  • 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?

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  • Tissue Tracking Failures and Lessons Learned - Hope for the Future

    10 August, 2010 Scott A. Brubaker, CTBS, Chief Policy Officer, American Association of Tissue Banks

    Note: The opinions expressed by the author in this manuscript are not necessarily representative of the membership of the AATB.

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  • New Commercial Models for New Market Realities

    9 August, 2010 Chris Nickum, VP and Global Practice Leader, Commercial Effectiveness, IMS Health Management Consulting

    Maximizing the efficiency of commercial operations is standard fare for companies operating in a difficult economy and with budget constraints. Yet, because the pharmaceutical world is moving towards heavier commoditization, with 75-80 percent of mature markets expected to be undifferentiated by 2015, creating commercial efficiencies is no longer simply about managing costs - it's about devising a New Commercial Model (NCM) that better leverages available or yet-to- be-discovered approaches to

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  • Reducing Human Error on the Manufacturing Floor

    15 June, 2010 MasterControl

    As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in the pharmaceutical and related manufacturing environments. Sadly, little is known about the nature of these events mainly because quality event investigations end where human error investigations should begin.

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  • Developing a Supplier Scorecard

    23 May, 2010 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer w

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  • Management Review - Measuring the 'Heartbeat' of Your Quality Management System

    17 May, 2010 John Gagliardi, President of MidWest Process Innovation, LLC

    Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the Regulations (21 CFR, Part 820) and the standards (e.g. ISO 13485:2003 and ISO 9001:2000).

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  • How to Avoid Common IND Submission Pitfalls

    12 April, 2010 Meredith Brown-Tuttle, RAC, Chairperson of the RAPS Publication Board

    An Investigational New Drug Application (IND) is like an orchestra - it brings together many players with different specialties that need to work together in harmony to create a synchronous melody (in the case of the orchestra) or message about the compound (in the case of an IND). With one instrument out of tune or with one musician who does not play his or her part there will most certainly be a displeasing sound to the ear and a composition that is thrown off. The same can be said for a secti

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  • UK MHRA Expects 98 Percent of Adverse Event Reports - Did You Know?

    31 March, 2010 MasterControl

    This mandate, as most medical device companies and MHRA regulators can predict, won't be simple but can be mad less complex with the newly introduced web-based reporting system that will soon be launched by MHRA and will include alert mechanisms.

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  • Until April 2011, the FDA is taking comments regarding the recently issued PGx Draft Guidance

    8 March, 2010 MasterControl

    Until April 19, 2011 FDA is taking comments regarding the recently issued PGx Draft Guidance. The guidance documentation was written to provide recommendations to drug manufacturers regarding how genomic information can be used during the drug development process. According to GenomeWeb News the draft's primary purpose is "...helping drug developers evaluate how human genomic variations can affect the way drugs function in different people and how they can cause varying clinical responses."1 Als

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  • New Initiative Program for Medical Device Innovation

    15 February, 2010 MasterControl

    On February 8th of this year the FDA announced Innovation Pathway, a new program dedicated to the priority review of new medical devices. The first submission selected for the program is an upper-extremity prosthetic that is controlled by the brain. This device is a pilot and will help determine the efficacy of the program. The FDA will also ask for additional public comment regarding the program before it is implemented on a widespread basis.

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  • FDA Produces List of Common Deviations Found During Lab Inspections

    15 February, 2010 MasterControl

    During 2010, the FDA performed a large number of regulatory inspections and has compiled a list of the most common deviations found. According to www.labcompliance.com, 19 percent of the devations found on the list were "related to unvalidated lab test methods," and that "laboratory controls [issues] ranked as number 1." Additional data points of interest also include quality system and production process control systems which rank at 9 percent and 6 percent respectively. Also according to labco

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  • FDA is Developing a Standardized Format for REMS

    4 January, 2010 MasterControl

    Drug companies know how difficult it can be to develop a solid risk evaluation and mitigation strategy (REMS). In fact, the process can be so difficult that even those assigned to develop the strategy spend much of their time confused about what it is that the FDA wants/requires in a REMS.

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