MedMira Inc. has recently achieved registration to ISO 13485:2003.MedMira, a provider of rapid flow-through diagnostic technology, reports that the standard is formally recognized by the European Commission as a key quality assurance requirement for the CE Mark approval for medical devices. ISO…
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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.” The guide is a user-friendly manual that covers the…
Firstlogic Inc., a provider of enterprise information quality and mail-automation software, recently announced that Dendrite International has started using its data quality solutions to improve customer information management for Dendrite’s pharmaceutical and life sciences clients. Dendrite is a…
A new study by Best Practices LLC contains performance metrics from which pharmaceutical companies can perform gap analyses to assess manufacturing performance and identify improvement opportunities. “Pharmaceutical Manufacturing: Cost, Staffing & Utilization Metrics,” contains the following…
AMR Research recently released a study that predicts that the cost of compliance for companies will reach $80 billion over the next five years. The firm also estimates that regulated organizations will spend close to $15.5 million on compliance-related activities in 2005. Although an average…
Medidata Solutions Inc., an electronic clinical data management solutions provider, will provide Pro-Pharmaceuticals Inc. with a state-of-the-art electronic data capture technology for an upcoming clinical trial for cancer research. Medidata’s RAVE will allow Pro-Pharmaceuticals to correctly and…
More than 18 companies recently announced support for Microsoft Corp’s new Digital Pharma solution, a framework designed for the pharmaceutical and life sciences industries to improve their performance. The solution is applicable to many areas in the pharmaceutical value chain, from drug…
The International Society for Pharmaceutical Engineering will host a training series for those who are new to the pharmaceutical and biopharmaceutical industries next month in Denver. The courses will be held April 4–7. The offered courses include: Biotech Basics Biopharmaceutical Process…
Waters Inform 2005, a symposium for laboratory data management process improvement, will be held May 24–26 in Baltimore. The event will include tutorials covering the range of the Waters Laboratory Informatics suite: Empower, Millennium, MassLynx, NuGenesis SDMS, eLab Notebook, and the Q-DIS family…
Leading businesses identify customer satisfaction, cost savings and productivity improvements as the primary drives for their quality improvement initiatives, according to a new study from Best Practices LLC. Based on analyses from 46 major companies, the survey concludes that: There is a…
PTI International Inc., an accredited provider of online continuing pharmaceutical education, will offer several upcoming courses on compliance to 21 CFR Part 11. The course, “How to Develop and Implement Risk-Based Strategies,” is designed to help attendees improve compliance with regulatory…
Purdue Pharma recently started to integrate radio frequency identification (RFID) tags into its packaging to prevent drug counterfeiting.The company will use RFID products produced by Symbol Technologies Inc. for the pilot project, which began with the RFID tagging of 100-count bottles of OxyContin…
Thomson Scientific & Healthcare Corp., a provider of integrated information products for the health care industry, recently introduced a new pharmaceutical product labeling solution that complies with impending FDA regulations. Thomson is now offering outsourced label conversion using its…
An upcoming conference focusing on stability testing will feature several major pharmaceutical and biotechnology companies. The “Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry” conference will be held March 7–8 at the La Jolla Marriott in San Diego. It…
The 6th annual Market Development & Outreach Multicultural Pharmaceutical Conference will be held March 17–18 in Iselin, New Jersey.The event is intended for pharmaceutical and health care companies that produce or develop products for diabetes, heart disease, cancer, HIV/AIDS, hepatitis and…
The Regulatory Compliance Workshop Group will present the 2005 Pharma IT Compliance Week training event March 7–11, in Puerto Rico. The event will feature five one-day workshops, with topics including “Auditing Computerized Systems to Pass FDA and European Regulatory Standards,” “Understanding and…
Pharmaceutical companies are strengthening their quality assurance programs to comply with government regulations and customer expectations, according to a new survey published by Best Practices LLCThe research firm surveyed seven major pharmaceutical companies and found that they’re striving to:…
Frost & Sullivan recently awarded Puritan Bennett, a provider of respiratory products, its 2004 Product Quality Leadership Award. The award was in recognition for Puritan Bennett’s innovative HELiOS Personal Oxygen System, which makes it possible for people requiring supplemental oxygen to “…
Statit Software will host a seminar that examines the use of statistical process control in the health care industry. The two-day seminar, to be held Feb. 7–8 in Corvallis, Oregon, will be facilitated by Marilyn and Robert Hart, authors of Statistical Process Control for Health Care. The seminar…
An upcoming conference in India will explore quality principles in the health care industry. “Quality Health Care in a Changing Environment: Opportunities & Challenges,” will be held in Mumbai, India, Feb. 5–6. It’s being organized by Seth GS Medical College and KEM Hospital, in collaboration…
QA Edge Inc., an FDA 21 CFR Part 11 consultancy, was recently recognized as one of the Philadelphia area’s fastest-growing privately held companies. The company was named on the Philadelphia 100, an annual list of emerging and fast-growing companies expected to gain significant market share in the…
Rollomatic Inc. recently released the LS-Smart, a noncontact laser-based system that measures run-out and the diameter of surgical and medical cutting tools. The device was specifically designed to accommodate long, thin components with run-out issues. A double V-block system allows the user to…
Brady/TISCOR recently released Medi-Mizer 12, an enhanced version of its biomedical equipment management software. The new software features a special emphasis on plant engineering and maintenance inspections at health care facilities. Used with mobile hand-held computers and bare code technology…
Brooks Software and AssurX Inc. recently released the first real-time electronic device history record (eDHR) software for the medical device industry. The eDHR solution incorporates components of both companies’ software and allows medical device manufacturers to convert their paper-based device…
BSI Management Systems will host several training options for professionals interested in medical device training. “Understanding ISO 13485” is a one-day course designed to give attendees a broad understanding of the standard and its requirements. It also gives an introduction to the concept of…
