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Stelex University recently provided a training session for the Food and Drug Administration’s National Center for Toxicology Research (NCTR) that focused on computer systems validation. Stelex University is Stelex’s professional education and technical training department. Its training…
Microsoft Corp. recently announced the winners of its Pharmaceutical and Life Sciences Innovation Awards 2006 competition. The awards were presented at the annual meeting of the Drug Information Association in Philadelphia, and were given to companies that have demonstrated the best use of…
Parsec Automation Corp. has enhanced the 4.04 version of its TrackSYS software to better serve pharmaceutical and medical device–industry users. The company reports that many pharmaceutical and medical-device makers believe that their plants have an operating efficiency in the 60-70 percent range,…
Veriteq Instruments Inc. recently released the enterprise version it its viewLinc monitoring and alarming software. viewLinc Enterprise is designed for applications demanding immediate notice of out-of-compliance environmental conditions. It is a quick method of arranging complete…
iAdvantage Software Inc. and StatSoft Inc. have partnered to deliver a full array of statistical and visualization capabilities with an upcoming software release. eStudy version 5.0 will include StatSoft’s WebSTATISTICA engine, giving life-sciences users statistical and analytical…
The Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced four new members of its Guiding Principles Independent Review Panel.The new panel will review trends in direct-to-consumer (DTC) advertising as they relate to PhRMA’s voluntary Guiding Principles on Direct…
DDL Inc., a medical device package testing lab, will present a webinar to explain upcoming revisions to ISO 11607.The standard applies to organizations that package terminally sterilized medical devices. “Understanding Clause 6” will focus on a package’s ability to deliver a medical…
Rochester Medical Corp. recently signed agreements with Coloplast A/S and Mentor Corp. regarding Coloplast’s acquisition of Mentor’s urology business.Under the agreements, Rochester Medical will acquire certain assets of Coloplast and Mentor related to male external catheters in the United…
The Michigan Economic Development Corp. and Michigan Manufacturing Technology Center recently presented four Michigan hospitals with awards for significant successes with a lean Six Sigma pilot program.The awards were given to Bay Regional Medical Center, Gratiot Medical Center, Mercy…
TÜV America Healthcare Specialists, TÜV SÜD AG, founded as a joint venture between Healthcare Specialists Inc. and TÜV America Inc., will host a fall seminar in two U.S. cities. “Getting the Most From Your Accreditation Efforts With the Integrated Accreditation Program of the NIAHO and…
The benefits of implementing good manufacturing practices (GMP) and quality management could be made easier for the pharmaceutical industry with a new standard from the International Organization for Standardization. ISO 15378:2006, "Primary packaging materials for medicinal products—…
The U.S. Food and Drug Administration recently issued an updated list of agency-approved consensus standards for the evaluation of medical devices. "Modifications to the List of Recognized Standards, Recognition List Number: 014" includes more than 50 changes to the FDA’s roster of…
Peter R. Dolan, chief executive officer of Bristol-Myers Squibb, was recently elected chairman of the Pharmaceutical Research and Manufacturers of America. Also elected were Kevin Sharer, Amgen president and CEO, as PhRMA board’s chairman-elect; and Karen Katen, Pfizer vice chairman, as…
The Partnership for Prescription Assistance, a national program sponsored by pharmaceutical research companies, recently commemorated its first anniversary by launching the first "Patient Assistance Day" and by enhancing its services. The PPA provided free and reduced-cost prescription…
Improvement teams from Merck & Co. Inc., Pfizer Inc. and Wyeth Pharmaceuticals have been named finalists in the 2006 Team of the Year awards. Now in its second year, the competition is sponsored by Putnam Media and Pharmaceutical Manufacturing magazine, and recognizes manufacturing…
The federal Office of Personnel Management now requires preferred provider organizations (PPOs) and other fee-for-service plans to collect and report quality performance measures. Beginning in 2007, 8 million federal employees, dependents and retirees will have better comparative…
The Medical Device Manufacturers Association (MDMA) recently asked Congress to eliminate allegedly anticompetitive practices in the hospital supply industry. Mark Leahey, MDMA executive director, urged the Senate Judiciary Antitrust Subcommittee to protect patients from exclusionary practices…
Using prescription medicines to treat untreated and undertreated high blood pressure could prevent thousands of heart attacks, strokes and deaths in every U.S. state, according to a recently released study. “Reducing the Human Impact of High Blood Pressure,” examined the annual numbers…
Laser surgeons from around the world will gather April 5–9 for the 26th annual scientific meeting of the American Society for Laser Medicine and Surgery in Boston. Laser 2006 will be held at the Sheraton Boston Hotel and Hynes Convention Center. The event will offer a diverse line up of…
Millstone Medical Outsourcing Inc. recently signed agreements with several medical device companies to provide post-manufacturing solutions to overcome start-up challenges. The company has contracted with Blackstone Medical Inc., Decision Biomarkers Inc., Ingen Orthopedics and Spine Wave…
Topas Advanced Polymers, a producer of polymers for the medical-device and packaging manufacturers industries, recently received the 2005 Frost & Sullivan Award for Technology Leadership. The award is given each year to a company that has demonstrated excellence in technology…
The National Committee for Quality Assurance has released a draft standard of its 2007 accreditation requirements for public comment. The draft includes increased requirements for managed care organizations and preferred-provider organizations seeking accreditation. They’ll be required…
Heightened awareness among electrosurgical-device companies and health care consumers about the potential spread of communicable diseases during surgery has increased market demand for disposable surgical devices. While this is good news for large-scale manufacturers, high expec-tations…
Cognex Corp. will host a series of complimentary machine vision seminars for pharmaceutical professionals involved with packaging operations. The half-day seminars, titled “Applying Machine Vision to Pharmaceutical Packaging” will be held in March and April in Indiana, Michigan, New Jersey…
Digirad Corp., a provider of cardiovascular imaging services and solid-state nuclear medicine imaging products, recently achieved registration to ISO 13485:2003. The standard specifies a quality management system for medical device manufacturers and complies with the Canadian Medical…