Albuquerque, NM Jul 28, 2011 – A microbiology laboratory manager at OSO BioPharmaceuticals Manufacturing, LLC, has authored a chapter on environmental monitoring trends for an industry reference manual.
Kim Van Antwerpen wrote a chapter for “Environmental Monitoring: A Comprehensive Handbook (vol. 5)” edited by Jeanne Moldenhauer and being published in September by the Parenteral Drug Association.
Van Antwerpen’s key observation is that aseptic drug manufacturers should closely observe the environmental monitoring trends of their production facilities to ensure regulatory compliance and protect consumer health.
OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. The company is known for its expertise in difficult–to–manufacture, demanding or highly potent products.
In her chapter, Van Antwerpen wrote that each aseptic drug manufacturer should have a clear understanding of its unique environmental monitoring profile in order to pro–actively execute preventive or corrective steps if an adverse trend is detected.
“The manner in which data are trended influences all stakeholders – both internal and external – and affects resulting opinions of one’s environmental monitoring program, perceptions of control at the production facility, and actions taken to mitigate potential risks,” she stated. “When trends are presented in a concise, thorough and understandable manner, the company gains credibility.”
Van Antwerpen will be a featured speaker at the PDA’s sixth annual Global Conference on Pharmaceutical Microbiology, taking place Oct. 17–19 in Bethesda, Md. She will discuss how to trend environmental data using commonly available software presentation, as well as how best to implement an environmental review board.
Van Antwerpen holds a bachelor’s of science degree in microbiology from the University of Wisconsin–La Crosse and a master’s degree in business administration from the University of Phoenix. A Lean Six Sigma black belt, Van Antwerpen is a member of the Parenteral Drug Association – for which she serves on its program steering committee – and a senior member of the American Society for Quality.
Month: July 2011
U.S. HealthWorks Acquires Three Minneapolis-area Medical Centers
Minneapolis, MN Jul 27, 2011 – U.S. HealthWorks, a leading operator of occupational healthcare centers nationwide, today announced the acquisition of the NorthWorks Occupational Health centers. The three centers are the company’s first in Minnesota.
The newly acquired centers are all in the Minneapolis-St. Paul area and bring the total number of U.S. HealthWorks medical and worksite centers to 156 nationwide. The centers are located at 7550 34th Ave. South in Minneapolis; 4080 W Broadway, #200 in Robbinsdale; and at 1580 White Oak Drive, Ste 100 in Chaska.
All three facilities offer occupational medicine services, including diagnosis and treatment for injury and illness, preventive services, pre-employment and post-offer exams and screening, and return-to-work rehabilitative care. Terms of the transactions, effective July 27, 2011, were not disclosed.
“In analyzing potential partners for our organizations, U.S. HealthWorks stood out for its commitment to quality and its innovative approaches to providing care and working with clients to minimize workplace injuries and help employees recover and return to work quickly,” said John Capouch, CEO of NorthWorks.
“NorthWorks is well known in the Minneapolis area for providing high-quality care, and we are pleased to have their talented team join us,” said Gregory Marotta, vice president of operations, eastern division, for U.S. HeathWorks. “By extending our network into Minnesota, we will be able to serve our national clients who have operations in the Minneapolis-St. Paul area.”
M2S announces the addition of hemodialysis access to its Clinical Data Pathways registry
West Lebanon, NH Jul 26, 2011 — M2S, Inc., a leading provider of medical image and clinical data analysis services, announces the release of version 1.11 of its Clinical Data Pathways web-based registry. Clinical Data Pathways, utilized by the Vascular Quality Initiative (VQI) is a secure, web-based data collection and analysis system that provides real-time benchmarked reports and facilitates local, regional, national, and international data collaboration.
With version 1.11, hemodialysis access procedure and follow-up forms have been added to the Pathways quality improvement database, enabling the Vascular Quality Initiative to now collect perioperative and one-year follow-up data on nine vascular procedures – carotid endarterectomy, carotid artery stent, open and endovascular repair of abdominal aortic aneurysms, infra-inguinal and supra-inguinal bypass, peripheral vascular intervention, thoracic and complex endovascular aortic repair, and hemodialysis access. VQI currently includes 90 participating centers spread across the United States and Canada. In total, the Initiative has collected data on more than 27,500 procedures. These institutions also participate in regional quality groups through the Society for Vascular® Surgery Patient Safety Organization (SVS PSO), for the sharing and analysis of data through anonymous, benchmarked reports to initiate quality improvement projects in an effort to improve patient care and the quality of vascular health care.
With the latest release of Clinical Data Pathways, M2S has also expanded the Carotid Artery Stent (CAS) procedure form to include the collection of isolated and proximal common carotid stents, giving participating centers the ability to collect data on all CAS procedures in order to meet the requirements of the Centers for Medicare and Medicaid Services’ Carotid Artery Stent Facility Recertification.
Future updates to Pathways include the addition of an amputation procedure module and integration of M2S’s 3D imaging measurement data into VQI to provide customers with a comprehensive patient management system.
Sparta Systems to Present on Future-Proofing CAPA Processes at Medical Device Summit Educational Workshop
Washington, DC Jul 11, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will be presenting a session at “CAPA: Corrective Action, Preventive Action, Related Processes and Best Practices,” a two-day interactive workshop presented by the educational division of the Medical Device Summit. Tim Mohn, Industry Principal for Sparta Systems, will speak in an educational session titled “Future-proof Your CAPA Processes,” as he outlines tips, tactics and best practices for implementing and maintaining a quality system strategy in a changing environment.
Medical device organizations are in a state of constant change, whether due to centralization of existing processes or other external factors such as mergers and acquisitions. For these companies, it’s critical to ensure that the ability to initiate corrective and preventive actions (CAPAs) for issues that arise in the manufacturing operation is not affected by any organizational changes that may occur. This presentation from Sparta Systems will provide companies with proven strategies for how to “future-proof” their own CAPA processes, ensuring that existing processes continue to operate in the event of organizational change and that product quality is maintained regardless of any issues that do arise.
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Sparta Systems to Present on Future-Proofing CAPA Processes at Medical Device Summit Educational Workshop
WHAT: Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will be presenting a session at “CAPA: Corrective Action, Preventive Action, Related Processes and Best Practices,” a two-day interactive workshop presented by the educational division of the Medical Device Summit. Tim Mohn, Industry Principal for Sparta Systems, will speak in an educational session titled “Future-proof Your CAPA Processes,” as he outlines tips, tactics and best practices for implementing and maintaining a quality system strategy in a changing environment.
Medical device organizations are in a state of constant change, whether due to centralization of existing processes or other external factors such as mergers and acquisitions. For these companies, it’s critical to ensure that the ability to initiate corrective and preventive actions (CAPAs) for issues that arise in the manufacturing operation is not affected by any organizational changes that may occur. This presentation from Sparta Systems will provide companies with proven strategies for how to “future-proof” their own CAPA processes, ensuring that existing processes continue to operate in the event of organizational change and that product quality is maintained regardless of any issues that do arise.
WHO:
Tim Mohn, Industry Principal for Sparta Systems and former Manager, Worldwide Quality Systems for Johnson & Johnson Ortho-Clinical Diagnostics
WHEN:
“Future-proof Your CAPA Process”
Friday, July 15, 2011, 8:30 a.m. – 9:00 a.m.
WHERE:
Georgetown University Hotel and Conference Center
3800 Reservoir Rd. NW
Washington, DC 20057
Seasoned Healthcare Communications Professional Joins Precyse Executive Leadership Team
Wayne, PA and Alpharetta, GA Jul 12, 2011 — Precyse, a leader in health information management (HIM) services and technologies, has announced that Kristen Saponaro has joined the organization’s executive leadership team as Vice President of Marketing. Saponaro, who has extensive experience in marketing for healthcare and healthcare technology, will be responsible for the overall leadership of both internal and external marketing for Precyse.
Saponaro, most recently, was the principal of Saponaro Communications, LLC, the consulting firm that supported Precyse in its recent rebranding and launch of a new corporate identity. Saponaro Communications served a wide range of clients, including Precyse, Siemens Healthcare, NextGen Healthcare, the Department of Homeland Security and others with marketing, public and government relations, corporate communications, branding and advertising programs.
“It gives me great pleasure to welcome Kristen to our executive leadership team,” said Precyse President Chris Powell. “She did a tremendous job in assisting us with our new corporate identity, rebranding and other key marketing communications initiatives, and her appointment as a member of the Precyse team is just a natural extension of the success of those efforts. Her addition to our Marketing group will allow us to focus on educating the market on our new products, promoting our services and ensuring that our message is on track with our mission and values.”
Before founding Saponaro Communications, Saponaro was Director of Marketing for Executive Health Resources, the leading provider of medical necessity compliance solutions to hospitals nationwide. Before that, she was Corporate Affairs Manager for Siemens Medical Solutions, where she was responsible for communicating the company’s corporate messages to enhance image and identity. Other past positions include Public Relations Manager for brand communications firm Brownstein Group, Director of Educational Outreach for Search for Common Ground and a Senior Account Executive for the Fleishman-Hillard public relations firm. Saponaro has won numerous awards on behalf of her clients and employers, including MM&M Gold Awards, Stevie Awards and Marketer of the Year Award for Siemens Medical Solutions, as well as numerous Philadelphia Public Relations Society of America Pepperpot Awards and SABRE Awards, the world’s largest awards competition for the public relations industry, celebrating PR campaigns that demonstrate the highest levels of creativity, integrity and effectiveness.
Saponaro holds a bachelor of arts degree in political science from St. Joseph’s University and a master’s degree in congressional studies from The Catholic University of America. She is a member of the Public Relations Society of America and was a member of the society’s Philadelphia Chapter Agency Leadership Council from 2004 to 2007.