http://www.gxpandjvt.com/IVT News Channelhttp://www.gxpandjvt.com/ivtnews/templates/?a=1983&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1727&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1724&z=27William E. Hall, Ph.D. has a combined 50 years of experience in the pharmaceutical industry. He is a technical pharmaceutical consultant with Hall & Pharmaceutical Associates, Inc. in North Carolina. He has consulted with more than 500 clients worldwide on the subjects of process validation, cleaning validation, quality assurance, quality control, GMP inspections, development facilities, new product development, new company start up, APIs, excipients, devices, and vendors.http://www.gxpandjvt.com/ivtnews/templates/?a=1721&z=27Ms. Green has over 30 years of technical, regulatory, and quality experience with an additional four years of “hands on” research and development experience. Cindy has organized and established GMP/GCP/GLP/GTP compliance programs. She has managed a full range of regulatory submissions for drug, medical device, and biologic products; international submissions and export applications; validation plans; and environmental control programs for multi-use facilities. http://www.gxpandjvt.com/ivtnews/templates/?a=1717&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1709&z=27Current list of JVT and GXP articles, for sale, and available for immediate download in pdf format.http://www.gxpandjvt.com/ivtnews/templates/?a=1706&z=27Journal of GXP Compliance Editorial Advisory Board Spotlight: Tim Fields is president of Drumbeat Dimensions, Inc., a validation and compliance management consulting company, and has over 25 years of experience in the pharmaceutical industry. Mr. Field’s experience includes 13 years with Pfizer where he was responsible for organizing and managing the corporate software quality assurance audit program, developing GMP training programs for management level personnel, and conducting numerous internal and external quality audits. http://www.gxpandjvt.com/ivtnews/templates/?a=1691&z=27Journal of GXP Compliance Editorial Advisory Board Spotlight: Dr. Matthew D. Whalen is a principal of IMPACT LLC, a consulting firm working with US federal government healthcare and research agencies. In addition, he serves on Boards of Directors including the Pharmaceutical Safety Institute, where he is also Vice President, and of a leadership development company serving the financial services and education sectors; as well as on the company Foundation’s Executive Committee.http://www.gxpandjvt.com/ivtnews/templates/?a=1690&z=27The 2008 redesign of the journals has resulted in a new layout, look, and a variety of new content that includes regular columns, increased interactivity, and expanded topics. It is a goal of the journals to add reactions and commentaries regarding current industry news and to invite our readers to submit their own experiences and opinions. Practical tools such as sample charts, graphs, spreadsheets, and appendices will be available online for download.http://www.gxpandjvt.com/ivtnews/templates/?a=1655&z=27The Journal of GXP Compliance and the Journal of Validation Technology are peer-reviewed publications.http://www.gxpandjvt.com/ivtnews/templates/?a=1614&z=27 The current audit approach is limited in its scope and ability to achieve sustainable regulatory compliance. This article describes a new approach to use Good Manufacturing Practice (GMP) assessments as tools to evaluate leadership at different levels in the organization and to correct issues through the development of required leadership competency for reducing the company’s regulatory compliance risk.http://www.gxpandjvt.com/ivtnews/templates/?a=1605&z=27Not all medical devices require clinical investigation in order to demonstrate their safety and efficacy. But, even for some class II medical devices that can be cleared by the Food and Drug Administration (FDA) through the 510(k) process, some degree of clinical testing may be required.http://www.gxpandjvt.com/ivtnews/templates/?a=1604&z=27Events, which are presented as scenarios or stories, can sometimes make a point more effectively than lectures on the importance of qualification. The author herein offers some scenarios that are summaries of actual events. He then highlights the qualification and change control implications of each. These scenarios can be used for background reading on the adequate application of Installation Qualification (IQ) and Operational Qualification (OQ) or change control. Alternatively, the scenarios may be used for interactive discussion of these topics. http://www.gxpandjvt.com/ivtnews/templates/?a=1603&z=27The September 18, 2006 European edition of Time Magazine1 carried three interesting letters from readers on the subject of airline security and the related governmental risk control measures. Under the heading “How Much Risk Can We Take?” the letters showed, in very simple terms, how the perception of risk and risk control measures can be widely subjective, and how there can be much perceived uncertainty in the approaches used for managing risks.http://www.gxpandjvt.com/ivtnews/templates/?a=1602&z=27Some degree of clinical testing is required to demonstrate the safety and effectiveness of certain Medical Devices. In some cases, feasibility testing of a device on a limited number of human subjects may be necessary as part of fundamental research and development.http://www.gxpandjvt.com/ivtnews/templates/?a=1497&z=27This article provides an overview of currently accepted quality requirements for the conduct of clinical trials and is intended to serve as an introduction to that area of the regulated environment recognized as the quality standards employed in clinical trials around the world and referred to collectively as Good Clinical Practice (GCP).http://www.gxpandjvt.com/ivtnews/templates/?a=1446&z=27The discipline of cleaning validation is as individual as process validation, but the methods, techniques, and risks are almost identical in all kinds of pharmaceutical manufacture. Process understanding is the magic term when assessing what must be done and the effort to be put into the documentation of equipment status.http://www.gxpandjvt.com/ivtnews/templates/?a=1443&z=27In the European Union (EU), the Good Manufacturing Practice (GMP) requirements place specific obligations on manufacturers of medicinal products to implement risk-based qualification, validation, and change control programmes.http://www.gxpandjvt.com/ivtnews/templates/?a=1442&z=27Someone once asked me, “How did you become a Validation Consultant?” I had to stop and think. I began a trip down memory lane covering the last thirty years of my business career in an attempt to find that errant milestone, and I am still unsure about the specific point in my life when it occurred. I am totally convinced that no one wakes up one day and announces that they would like to pursue a career as a validation engineer. . .http://www.gxpandjvt.com/ivtnews/templates/?a=1441&z=27This technical paper summarizes information compiled from a literature review on basic concepts of Electron-Beam technology: the radiation process, operating mechanisms, process control, and validation. The primary intent of this descriptive overview is to present the potential use of ionizing radiation as lethal agent against microorganisms (sterilization method), and provide general guidance for validation.http://www.gxpandjvt.com/ivtnews/templates/?a=1440&z=27Process validation is a requirement in heavily regulated industries such as the automotive and aerospace industries. Both the International Organization for Standardization (ISO) 9000/13485 and the U.S. Food and Drug Administration (FDA) Quality System Regulations (QSR) 820 Part 21 Code of Federal Regulations (CFR) “Quality Systems for Medical Devices,” require process validation as a regulatory requirement.http://www.gxpandjvt.com/ivtnews/templates/?a=1439&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1217&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1216&z=27Institue of Validation Technology offers many free articles from past Journals. Here are just a fewhttp://www.gxpandjvt.com/ivtnews/templates/?a=1198&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1197&z=27http://www.gxpandjvt.com/ivtnews/templates/?a=1196&z=27