Susan Schniepp, VP of Quality at OsoBio, Elected to PDA Board of Directors

Albuquerque, NM Jan 26, 2011 – Susan Schniepp, vice president of quality at OSO BioPharmaceuticals Manufacturing, LLC, has been elected to the board of directors at the Parenteral Drug Association (PDA).
Schniepp has enjoyed a long and productive relationship with the PDA. In addition to serving on numerous committees and being a featured speaker at events, she received the PDA’s Distinguished Author Award for her book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process.
Schniepp also received the PDA’s Distinguished Service Award in 2008 and its Gordon Personeus Award in 2010, which honors a long–time member for noteworthy contributions to the organization.
“Sue is a shining star within our industry for her unflagging commitment to high quality and her willingness to share her knowledge and experience with others,” said Stuart Rose, president and CEO of OsoBio. “Serving on the PDA board affords Susan yet another opportunity to spread the quality message and lead by example.”
In managing all operational quality–related issues for OsoBio, Schniepp is responsible for cGMP compliance of facilities. Quality–related matters concerning validation as well as regulatory affairs, records and filings also fall under her scope of responsibility.
Recently, Schniepp served as chairwoman of the Monograph Development–Psychiatrics and Psychoactives Expert Committee for United States Pharmacopeia (USP), a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other health–care products manufactured or sold in the United States. USP standards for quality, purity, strength and consistency are recognized and used in more than 130 countries.
As the first woman appointed to serve on the editorial advisory board of Pharmaceutical Technology magazine, Schniepp writes the publication’s quarterly column, “Inside Standards.”
Schniepp’s term on the PDA board of directors is for two years.
PDA was founded in 1946 by a small group of pharmaceutical manufacturers who recognized the need to disseminate technical information within the industry. Today, with more than 10,000 members worldwide, PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology.
OSO BioPharmaceuticals Manufacturing, LLC, is a contract manufacturing organization (CMO) focusing on biologic and pharmaceutical injectables. Headquartered in Albuquerque, N.M., OsoBio specializes in products requiring complex handling, including highly potent compounds. Responsiveness, attention to detail and clear communication are the hallmarks of our client care.

The Food Safety Modernization Act: Best Practices for Manufacturers to Prepare for Regulatory Changes

Holmdel, NJ Jan 26, 2011 – On Jan. 4, 2011, President Obama signed into law one of the most comprehensive changes to U.S. food safety since the Food, Drug and Cosmetic Act of 1938. The Food Safety Modernization Act gives the Food and Drug Administration (FDA) and related government agencies the authority to develop and enforce more stringent standards and more severe penalties for food manufacturers not in compliance with new regulations.
Across the industry, organizations can expect the upcoming changes to food safety standards to result in more frequent on-site audits and more rigorous testing requirements for food manufacturers; expanded authority for the FDA to initiate product recalls; additional records required in safety data collection; and stronger industry-wide safety standards.
Sparta Systems’ team of quality experts advises food manufacturers to proactively evaluate their quality and compliance processes in preparation for upcoming changes. The following are best practices for ensuring the safety of products delivered to consumers and for responding to quality incidents in a timely fashion:
• Monitor critical processes, identify gaps and improve regulatory compliance with audit management. While regulatory compliance questions are being raised in light of recent food safety headlines, manufacturers should always implement proactive measures to collect data resulting from supply quality incidents, take the necessary steps to investigate these incidents and report all critical data to regulators.
• Safeguard supply quality with enterprise-wide supplier quality management tools. As food manufacturers source ingredients from more suppliers and locations around the globe, manufacturers need to identify and manage risks across the supply chain to protect both company stakeholders and, more importantly, consumers.
• Manage, track and report on nonconformances, investigations, complaints and other processes in food manufacturing operations. Food and beverage manufacturers need a holistic and centralized system in place to quickly respond to supply quality issues and limit the impact of incidents that can lead to a brand-damaging recall.
Overall, the impending changes introduced by the Food Safety Modernization Act necessitate more effective quality processes in food manufacturers’ operations. The most successful businesses will critically examine the advanced technologies available in the marketplace that can help food manufacturers go above and beyond today’s governmental guidelines and prepare for tomorrow’s regulatory changes.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 14 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.spartasystems.com.

Sparta Systems to Present on Change Control and Risk Management

Holmdel, NJ Jan 25, 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 present at the Institute of Validation Technology’s (IVT) upcoming 9th Annual Change Control Conference in a session titled, “Implementing an Enterprise-Level Change Control Solution – A Complex Process,” on Tuesday, Jan. 25, 2011, from 10:45 a.m.-12:15 p.m. Sparta will also present at IVT’s co-located Quality Risk Management Conference in a session titled “Integrating a Risk Management System with a Quality Management Solution,” on Thursday, Jan. 27, 2011, from 1:30 p.m.-3:00 p.m.
The current economic environment has forced companies to streamline their quality operations and more effectively harmonize processes across the global organization. Additionally, regulatory pressures stemming from high-profile product safety incidents have made it imperative for organizations to bolster their investments in technology as a way of minimizing risk and ensuring quality in the supply chain. As the global leader in quality management software solutions, Sparta Systems will offer attendees to these sessions proven strategies for leveraging technology to standardize change across the organization and integrating quality management and risk management solutions for a complete, enterprise-wide approach to these mission-critical functions.
WHO: Tim Mohn, Industry Principal for Sparta Systems and former Manager, Worldwide Quality Systems for Johnson & Johnson Ortho-Clinical Diagnostics
WHEN: “Implementing an Enterprise-Level Change Control Solution – A Complex Process” Tuesday, Jan. 25, 2011, 10:45 a.m.-12:15 p.m.
“Integrating a Risk Management System with a Quality Management Solution”
Thursday, Jan. 27, 2011, 1:30 p.m.-3:00 p.m.
WHERE: Sir Francis Drake Hotel
450 Powell Street
San Francisco, CA 94102

Oso BioPharmaceuticals Taps Craig Mastenbaum to Lead West Coast Business Development

Albuquerque, NM Jan 19, 2011 – OSO BioPharmaceuticals Manufacturing, LLC, has named Craig Mastenbaum director of new business development for its West Coast market.
Mastenbaum brings to OsoBio more than 30 years of leadership experience in clinical and contract liquid, lyophilized, ampule and syringe product manufacturing. Most recently, he was senior director for clinical and contract manufacturing for Dendreon Corp., a biotechnology company that develops anti-cancer agents.
“Craig has personally directed both the in-house and outsourced manufacturing of complex, sterile liquid pharmaceutical products and been responsible for ensuring key performance and quality assurance indicators,” said Milton Boyer, vice president of business development and sales. “He understands exactly what clients are looking for and how OsoBio can best meet their needs.”
Previously, Mastenbaum served as vice president of manufacturing and business development at Hollister-Stier Laboratories, where he quadrupled contract revenues, and as director of parenteral operations at Chiron Corp. He holds a bachelor’s of arts degree in microbiology from Rutgers University and a master’s degree in business administration from Gonzaga University.

Paragon Medical Announces Opening of Bioskills Lab

Pierceton, IN Jan 19, 2011
Pierceton based Paragon Medical announced today the official opening of its new Bioskills Lab at its headquarters in Pierceton, Indiana. Company management and employees were joined at a ribbon cutting on January 19, 2011 by the Warsaw / Kosciusko Chamber of Commerce and other local officials to commemorate this important event for the company and the community.
In December 2009, Paragon announced that through its Orthopaedic Instrument Global Design Center (OIGDC), it would accelerate the construction of this new lab in direct support of OrthoWorx, a Warsaw-based industry, community and education initiative established to advance and support growth and innovation within the region’s globally significant orthopaedics device sector.
The fully staffed facility is ready for client scheduling and includes capacity for up to four cadaveric evaluation stations and targets the comfort of lab attendees through ergonomic tables, laminar airflow, separate temperature zones, and a private conference room with a viewing window into the lab. A multitude of other services are available upon request including specimen procurement and preparation, instrument cleanup in a state of the art instrument disinfection system, C-Arm and Arthroscopy Tower rentals, audio-visual connectivity, and full catering capabilities.
According to Van Flamion, Director of the Bioskills Lab and Paragon’s OIGDC, “The lab was designed and constructed for the sole purpose of providing our customers a convenient, cost effective, full service facility where orthopaedic and other medical device companies can perform cadaveric studies on their products and / or train their surgeons or field representatives on surgical techniques pertaining to their products”.
Mr. Flamion also commented that a soft launch phase was conducted with a limited and controlled number of labs during the fourth quarter of 2010. The Bioskills Lab exercised its logistics as a full service facility while gathering critical customer feedback to ensure optimization prior to going to its now full-launch status.
For lab scheduling or additional information you can contact the Bioskills Lab directly or visit their website at paragonmedical.com/bioskillslab.

Geisinger Health System, Precyse Solutions and M*Modal Announce Strategic Partnership to Improve Clinical Documentation and Billing Efficiency

Danville and Wayne, PA Jan 11, 2011 – Danville and Wayne, Pa., January 11, 2011—Precyse Solutions, a leader in health information management (HIM) services and technologies, M*Modal, a pioneer of advanced speech understanding technologies, natural language processing (NLP), and provider of on-­‐demand conversational documentation, and Geisinger Health System, widely recognized for its implementation of innovative care models, today announced a first-­‐of-­‐its-­‐kind partnership to improve clinical documentation and coding accuracy.
Precyse’s automated, clinical documentation and natural language processing-­‐enabled (NLP) coding software features a robust, ICD-­‐10-­‐ready, NLP-­‐assisted coding engine driven by state-­‐of-­‐the-­‐art NLP technology from M*Modal, that processes and understands human voice converting it to text and transforming it to information. This NLP-­‐enabled, automated coding technology bridges Geisinger’s electronic health record (EHR), dictation, transcription, coding and clinical documentation improvement (CDI) processes by capturing physician dictation, editing it, coding it and directing it into Geisinger’s EHR software platform.
Geisinger physicians will be able to dictate directly into the EHR with minimal impact to their current workflow patterns. Clinical information is electronically tagged to be easily searched, mined and analyzed by healthcare team members responsible for driving hospital care and outcomes. This solution will also accelerate an organization’s attainment of HITECH Meaningful Use.
The Precyse, M*Modal and Geisinger partnership will redesign revenue cycle workflow and will enhance coding efficiency while enabling fast and efficient responsiveness to physician queries. The partners aim to see this collaborative technology replicated across the country.
This single solution provides a snap shot of all necessary management, resource, and reporting tools for mission-­‐ critical health information management processes on one platform, easily monitored and managed through an easy-­‐to-­‐follow dashboard.
“Geisinger is eager to work with Precyse Solutions and M*Modal to innovate an enterprise-­‐wide solution to physician documentation in the EHR, creating vast opportunities for improvement across the documentation continuum,” noted Joan Topper, Vice President, IT Optimization, Geisinger Health System.
“Precyse is committed to finding newer and better ways to capture and format the clinical narrative to maintain health data integrity, drive EHR adoption and enable Meaningful Use compliance for our clients.” said Jeffrey Levitt, CEO and Founder, Precyse Solutions. “The reality today is that EHR implementation, adoption, and attaining Meaningful Use are major challenges for healthcare facilities and clinicians. Together with M*Modal, Precyse accepts physician affinity for dictation and transcription while meeting the facility’s objectives for improved healthcare delivery and superior information management. We are confident that this transformative partnership with Geisinger will surely generate extraordinary results.”
About Geisinger Health System
Geisinger is a an integrated health services organization widely recognized for its innovative use of the electronic health record, and the development and implementation of innovative care models including advanced medical home and ProvenCare® (“warranty”) program. The system serves more than 2.6 million residents throughout 42 counties in central and northeastern Pennsylvania. For more information, visit www.geisinger.org.

U.S. HealthWorks Acquires Fairbanks Urgent Care Center

Fairbanks, AK Jan 3, 2011 – U.S. HealthWorks, a leading national operator of occupational healthcare centers, today announced the acquisition of the Fairbanks Urgent Care Center. Located at 1867 Airport Way, Ste.130B, in Fairbanks, the facility will continue to offer urgent care, occupational medicine, and physical therapy services.
Terms of the transaction, effective December 29, 2010, were not disclosed. The move expands the number of U.S. HealthWorks operated medical centers in Alaska to five and nationwide to 134.
“We’re thrilled to expand our footprint in the great northwest and we look forward to serving our new Alaskan clients and patients,” said Dr. Andy Parker, senior vice president of operations. “Dr. Harikian brings with him a top-notch team that will undoubtedly continue to be a success in the region.”
“U.S. HealthWorks, with its national network of physicians and medical centers, will provide added innovation and resources, enabling us to expand the scope of our services,” said Dr. Larry Harikian, who will remain on as the center’s medical director. “Our facility will continue to offer quality medical services to the community, and now we’ll also be able to tap a larger network for added expertise and depth. This will be a very positive change for our patients and clients.”

HealthTech Offers New Medicaid Retroactive Eligibility Service

Franklin, TN Jan 1, 2011 — HealthTech today announced it is offering Medicaid Retroactive Eligibility Services for hospitals that are challenged with reimbursement of healthcare services for self-pay patients.
HealthTech’s Eligibility Service provides a retroactive review of self-pay patients for Medicare or other third-party payment source through one of its data partners. If a patient has qualified to receive financial assistance during the same time frame, the hospital can resubmit claims for back payments.
“We are excited to offer this new service to our clients,” said Derek Morkel, HealthTech CEO and President. “It can be very beneficial especially since there is a growing number of self-pay patients visiting community hospitals every year. It is another way we can help hospitals improve their revenue cycle and overall financial stability.”