• 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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  • Health Canada and FDA Agree to Perform Joint Third-Party Inspections

    4 January, 2010 MasterControl

    Both the FDA and Health Canada (HC) found the proposal of joint third-party inspections to be beneficial. The decision was made after the pilot Multipurpose Audit Program was conducted by the agencies.

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  • MasterControl All Access Equips Blood and Biologics Organizations

    4 January, 2010 MasterControl

    MasterControl's All Access solution is designed for life science professionals who need integrated, specialized solutions that address the many challenges in their unique work environments; for those professionals who have difficulty convincing management to invest in expert tools that would save the company money; for those who find that it's not cost effective to invest in general purpose tools that you only use once in a while; and for those who require a complete quality management system (Q

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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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  • 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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  • CHANGING TRENDS: Clinical Research Personnel Qualifications!

    Liz Wool, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.™

    In the last decade, clinical researchers have conducted clinical trials where their lack of knowledge of human subject protections embodied in Good Clinical Practices and ethical conduct for research (Belmont Report, Declaration of Helsinki) has resulted in clinical trial misconduct and subject deaths. Notably, these cases were reported in both our news media and professional publications.

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  • Status Means More than Prestige in Lifecycle Management

    Lane Hirning, MasterControl's Product Manager and Pharmaceutical Industry Expert

    Lifecycles are normal states of nature. Plants, animals, and all manner of things are born, live useful lives and die.

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  • Pharma Lifeline - FDA Report: Early and Effective Communication Key to First-Cycle Approval

    MasterControl

    Communication with FDA Key to Early NDA, BLA Approval

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  • Pros and Cons of Proposed PDUFA IV User Fee Increase From FDA - For Pharmaceuticals

    MasterControl

    FDA Proposes PDUFA User Fee Increase to Boost Drug Safety

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