http://www.gxpandjvt.com/IVT News Channelhttp://www.gxpandjvt.com/ivtnews/templates/?a=1727&z=31Current 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=31This presentation will discuss many aspects of standardization of Metrology/Instrument management. Mr. Gaurav Walia, M.S., will focus on key examples of major instrument types (HPLC, Dissolution, Mass Spec, etc.) and standardized management philosophies in regards to instrument qualification, re-qualification and calibration.http://www.gxpandjvt.com/ivtnews/templates/?a=1699&z=31Quality by Design is part of the FDA's 21st initiative and encompasses Process Analytical Technology, PAT, and ICH Q8, Pharmaceutical Development. Both PAT and Q8 make numerous references to using scientific and engineering principles along with a variety of terms that include mechanistic understanding, multi-factorial relationships, multivariate data acquisition, statistical design of experiments, response surface methodologies, methodological experiments, orthogonality, one-factor-at-a-time experiments, robustness, and interactions.http://www.gxpandjvt.com/ivtnews/templates/?a=1698&z=31WEB SEMINAR:Presenter Ludwig Huber, Ph.D. The new Part 11 regulation takes quite some time, but inspectors go out and focus inspections on computer systems and electronic-records for compliance with GMPs. Just in 2007/2008, there have more than 20 deviations related to computer system validation and Part 11compliance, some with disastrous consequences for inspected companies. Attend the seminar and learn how to avoid such warning letters.http://www.gxpandjvt.com/ivtnews/templates/?a=1681&z=31The Journal of GXP Compliance and the Journal of Validation Technology are peer-reviewed publications.http://www.gxpandjvt.com/ivtnews/templates/?a=1614&z=31 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=31Not 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=31Events, 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=31The 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=31SERIES TOPIC: Validation Basics A-Z: Planning, Implementing & Maintaining with Gamal Amer, now available on CD.http://www.gxpandjvt.com/ivtnews/templates/?a=1556&z=31If you were unable to attend one of these valuable sessions, you can now recieve this cost effective and timely training at your convenience.http://www.gxpandjvt.com/ivtnews/templates/?a=1518&z=31IVT offers CD recordings of our live WebSeminars, conducted by worldwide experts in the validation field. If you were unable to attend one of these valuable sessions, you can now recieve this cost effective and timely training at your convenience.http://www.gxpandjvt.com/ivtnews/templates/?a=1495&z=31Our expert presenter Karen Ginsbury provides tips and share her experience regarding the unique aspects and risks associated with packaging of drug product and placebo for blinded clinical trialshttp://www.gxpandjvt.com/ivtnews/templates/?a=1474&z=31Biological products are complex entities and that is why IVT has compiled the following into a useful, portable and spiral bound pocket guide. 21 CFR PART 600 – Biological Products: General, 21 CFR PART 601 – Licensing , and 21 CFR PART 610 – General Biological Products Standards http://www.gxpandjvt.com/ivtnews/templates/?a=1466&z=31This teleseminar event is now on CD. Conducted by Gamal Amer, PhD, a recognized expert in GMP compliance and validation with over thirty years experience in the pharmaceutical industry, will focus on developing an effective Validation Protocol.http://www.gxpandjvt.com/ivtnews/templates/?a=1454&z=31This 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=31The 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=31In 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=31Someone 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=31This 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=31Process 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=31The Institute of Validation Technology now offers its "Operations Combo" with 3 Great titles at one fantastic price! Facility Qualification, Utility Qualification and Equipment & Instrumentation Qualification have been combined into one resource Collection to assist you with your Validation Process. A 33% Savingshttp://www.gxpandjvt.com/ivtnews/templates/?a=1416&z=31This teleseminar conducted by Gaurav Walia M.S., a recognized expert in GMP compliance and laboratory quality, is intended to aid supervisors, laboratory chemists, metrology, QA, and others in ensuring that proper CGMP compliance is administered and maintained.http://www.gxpandjvt.com/ivtnews/templates/?a=1407&z=31The seminar includes instructions on how to: Plan and organize for the audit Select the focus areas – primarily the critical processes and direct impact systems. Execute and document the audit results. Report the audit observations, the departmental response and the closure of the item. This is cost effective and time effective training.http://www.gxpandjvt.com/ivtnews/templates/?a=1394&z=31The U.S. Food and Drug Administration (FDA) recently announced it is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction between the FDA and industry to optimize review times and foster innovation. Join us for this informative telseminar as we discuss this topic on Thursday, June 29, 2006.http://www.gxpandjvt.com/ivtnews/templates/?a=1393&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1246&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1243&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1241&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1239&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1217&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1216&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1210&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1209&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1208&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1207&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1206&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1205&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1204&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1203&z=31FDA changes the scope and application of Part 11 Electronic Records and Electronic Signatures. Download the Draft Guidance for Industry: Part 11, Electronic Records: Electronic Signatures - Scope and Application(pdf)http://www.gxpandjvt.com/ivtnews/templates/?a=1202&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1201&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1200&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1199&z=31Institue of Validation Technology offers many free articles from past Journals. Here are just a fewhttp://www.gxpandjvt.com/ivtnews/templates/?a=1198&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1197&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1196&z=3121 CFR Part 11: Implementing The use of electronic records and signatures is critical to FDA-regulated industries. It enables us to apply the computer, our most powerful tool, to a much fuller advantage. Learn Part 11 and understand its underlying principles from Industry experts and FDA officials.http://www.gxpandjvt.com/ivtnews/templates/?a=1194&z=31The master plan should be developed early in the life cycle, with input from the targeted user community, the quality unit (regulatory/compliance), and the information technology group...http://www.gxpandjvt.com/ivtnews/templates/?a=1193&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1192&z=31Excerpt from Special Edition: Computer Validation IIIhttp://www.gxpandjvt.com/ivtnews/templates/?a=1191&z=31Excerpt from Special Edition: Computer Validation IIhttp://www.gxpandjvt.com/ivtnews/templates/?a=1190&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1189&z=31This article will review the regulatory requirements, benefits and purposes, and typical contents of an APR.http://www.gxpandjvt.com/ivtnews/templates/?a=1188&z=31Pharmaceutical organizations have a training need for validation skills that cover the areas of protocol execution, protocol development, validation project management, and documentation control.http://www.gxpandjvt.com/ivtnews/templates/?a=1187&z=31http://www.gxpandjvt.com/ivtnews/templates/?a=1186&z=31Successful implementation of Corrective And Preventive Action(CAPA) is highly dependent upon the effectiveness of the planning that goes into it.http://www.gxpandjvt.com/ivtnews/templates/?a=1185&z=312009 IVT conference schedulehttp://www.gxpandjvt.com/ivtnews/templates/?a=1176&z=31