Idem Translations was the sponsor of the recent ACRP Northern California Chapter educational event “Medical Device and 510(k) Trials: Audits and Inspections” that was held on September 10. Approximately 102 attendees were able to benefit from this program, which answered many trial-related questions, provided information on how to prepare for possible inspection, and reviewed case studies of audits. Mariam Nayiny, President of Idem Translations, received a Certificate of Appreciation from ACRP. Also pictured below: Marygrace Barasi, Senior Project Manager (center) and Mariam Nayiny (right) chatting with an attendee at Idem’s tabletop display.
Idem Translations is proud to announce that the company has passed the re-certification audit with TÜV SÜD America and that the existing certification has been upgraded to ISO 9001:2008. Idem remains one of a few companies offering complete translation and localization services worldwide that is also ISO 9001:2008 certified.
“The ISO certification is important to our clients in regulated industries,” said Mariam Nayiny, President of Idem Translations. “It ensures that their critical documents are translated to meet both stringent regulatory requirements and high quality standards.”
Idem’s original ISO 9001:2000 certification was awarded on August 5, 2003 by the TÜV America, a subsidiary of Group TÜV Süddeutschland, Germany. ISO 9000 is a generic system standard that specifies the necessary components of a quality management system. Rather than being specific to any one industry, it details the basic requirements of the quality function for all industries. ISO 9000’s primary purpose is to provide organizations with useful, internationally recognized models for operating a quality management system. ISO 9001:2008 is the most recent revision of the ISO 9000 standard, which replaces the previous ISO 9000:2000 standard.
Idem Translations, attended and exhibited at the DIA 45th Annual Meeting in San Diego, June 22-24 at booth number 1231. The Annual Meeting featured over 350 sessions and 34 pre-conference tutorials focusing on issues affecting global drug discovery and development. Global drug development was also a key focus of the 45th Annual Meeting. This year’s event included sessions on issues affecting key regions of the world, including Asia Pacific, Australia, Emerging Markets, Europe, India and Latin America. More than 8,000 participants attended with over 1,100 speakers, including representatives from FDA, EMEA, and other global regulatory agencies. Idem’s booth was staffed by Nancy Kellen, Global Solutions Manager and Elaine Underwood, Marketing Manager. Pictured below: Elaine Underwood holding keys for the popular treasure chest game.
DIA is a professional association of more than 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products.
The ACRP (Association of Clinical Research Professionals) 2009 Global Conference & Exhibit took place in Denver April 24-28. Over 2,500 participants attended the conference, making it a great success. Over a 160 industry thought leaders from the drug, biologic, and device research industry spoke on topics ranging from Globalization of Clinical Research to Global Patient Recruitment to Recommendations on Conducting Studies in a wide variety of international locations such as India, Argentina, South Asia, Latin America, Japan and China.
Idem’s booth was staffed by Nancy Kellen, VP-Client Services, and Elaine Underwood, Marketing Manager. We enjoyed seeing some of our clients and having the opportunity to meet in person a lot of the industry principals.
About Association of Clinical Research Professionals
ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 30 years later, ACRP is a global association comprised of more than 20,000 individuals in over 60 countries dedicated to clinical research and development. Our mission: To provide global leadership to promote integrity and excellence for the clinical research profession.
For more information visit: www.acrpnet.org
The 2009 RAPS Horizons conference turned out to be a great success! Over 300 people attended the event. It was a nice occasion to see many of our clients and to learn about the changes taking place in the regulatory space. Pictured below: Elaine Underwood, Idem’s Marketing Manager in front of our new tabletop display.
ProZ.com is home to a highly respected community of language professionals who regularly interact within the site’s online marketplace. Thousands of linguists and translation companies network via ProZ.com each day. In September of 2008, Idem completed ProZ.com’s Certified PRO program, earning the “ProZ.com Certified PRO” title and seal. To be awarded this certification, a translation company must meet certain criteria, including Standards compliance or Defined processes, Business reliability, and Good citizenship.
In order to meet these requirements, Idem had to provide a statement of existing processes, maintain a good ProZ.com Blueboard record, earn positive customer, provider or partner references, maintain above-average company performance for two years, possess ProZ.com corporate membership, endorse professional guidelines, and exhibit excellent conduct.
Idem is honored to have been awarded the “ProZ.com Certified PRO” title and seal, and we will continue serving our clients and community with excellence.
On June 13th, 2008, Idem renewed its ISO 9001:2000 certification. To obtain such a certification, an organization must adhere to a strict set of standardized requirements for a quality management system. These requirements provide a systematic approach to process management, and are intended to promote consistency in an organization’s products and client satisfaction. Idem routinely audits its ISO 9001:2000-based quality system to ensure its ongoing efficiency. ISO certification is vital component of Idem’s commitment to consistently provide translations of the utmost quality.