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Press Releases

FDA's UDI Regulation Developer Will Help USDM Life Sciences Clients With UDI Compliance   SANTA BARBARA, CA--(Marketwired - Dec 19, 2013) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, hires Jay Crowley as Vice President of the Unique Device Identification (UDI) practice. As Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health, Crowley developed the framework and authored key requirements for the FDA's Unique Device Identification system. Crowley also lead the team responsible for the development and implementation of UDI requirements. At USDM Life Sciences,…
SANTA BARBARA, CA--(Marketwired - Dec 10, 2013) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce Wilfredo Santiago has joined the USDM Life Sciences team as Senior Manager of the Manufacturing Systems practice. Wilfredo Santiago will use his background in automated manufacturing equipment commissioning and qualification to help USDM Life Sciences' clients maintain compliance in the manufacturing environment. Santiago brings over 12 years of experience in FDA regulated industries involving medical device, pharmaceutical and biotech product manufacturers. He has provided consulting services to leading brand manufacturers such as Johnson &…
SANTA BARBARA, CA--(Marketwired - Nov 13, 2013) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce a teaming agreement with Inspirage to provide comprehensive consulting and technology solutions for medical device companies to meet FDA Unique Device Identification (UDI) compliance requirements. USDM supports Life Science companies' device identification and track-and-trace programs in both the medical device and pharmaceutical industries. As part of our comprehensive offering to meet the UDI regulation, USDM has partnered with Inspirage to offer a critical component of the UDI solution, the management of product specifications. The…
SANTA BARBARA, CA--(Marketwired - Nov 12, 2013) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is proud to announce the release of its newest validation accelerator, USDM Cloud Assurance VAP for Salesforce. USDM's Cloud Assurance VAP provides validation plans, requirements, tests and an industry proven methodology to ensure compliance in the cloud. USDM's Cloud Assurance VAP is a complete solution to meet FDA regulatory requirements including 21 CFR Part 11, in the Salesforce Cloud. Life Science companies can qualify and validate the Salesforce platform, Salesforce products and Partner Apps. "USDM Cloud Assurance addresses…
SANTA BARBARA, CA--(Marketwired - Oct 29, 2013) - USDM, a leading global regulatory consulting firm in the life sciences industry, is proud to announce their expansion of support around current and future device identification and track and trace regulations worldwide. Countries all over the world are focusing on being able to prove the authenticity of medical devices and pharmaceuticals. In the medical device industry, the primary goals are to be able to prove authenticity and identify exactly which devices, including version of components and software, are in the hands of a patient or medical facility. In the pharmaceutical industry, track…
SANTA BARBARA, CA - (Marketwired - Oct 1, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, has been invited to send two audit and quality systems professionals, Mr. Kevin Foley, former FDA pharmaceutical investigator, now Quality and Regulatory Compliance Subject Matter Expert and Global Auditor, and Mr. Robert Lesnefsky, V.P. of Global Quality and Auditing, to the Mumbai, India conference this October. Both Messrs. Foley and Lesnefsky will participate alongside fellow worldwide pharmaceutical leaders in sharing key expertise on auditing quality and compliance at CPhI's "Pharma Audit Excellence" (www.pharmaauditexcellence.com). This highly-subscribed conference includes attendees…
SANTA BARBARA, CA--(Marketwired - Sep 25, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, is proud to team with Oracle and Avnet in hosting the Life Sciences Social event at OpenWorld. This life sciences only OpenWorld party with fine wine and great company at the Press Club, offering the ultimate wine experience in one of San Francisco's most notable destinations, is the only life science networking event at OpenWorld. Our intent is to create a forum for a dialog about what it takes to achieve performance and compliance in the regulated life science industry.…
SANTA BARBARA, CA--(Marketwired - Sep 18, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, is proud to announce their support of current ECM industry technology changes by teaming with Generis who have been providing leading-edge software for content management systems including Documentum, SharePoint, Alfresco and Oracle WebCenter since 1997. USDM and Generis have partnered to provide CARA as a solution for Documentum clients looking to upgrade, move to a new platform, or replace FirstDocs or DCM. Generis has been providing software for content management since 2002, when the first version of CARA was released.…
SANTA BARBARA, CA--(Marketwired - Apr 24, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, is proud to welcome Kevin Foley, Senior GMP Auditor and Quality Subject Matter Expert. While Kevin will be predominantly involved in Quality, Auditing & Quality Management Systems engagements, he will also utilize his expertise in the Laboratory, GRC and Training areas to assist in meeting our client's quality and compliance needs in these key practice areas. With the addition of Kevin Foley and his FDA expertise to our Quality & Auditing Practice, USDM offers an un-paralleled combination of experience and…
SANTA BARBARA, CA--(Marketwired - Apr 23, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, is proud to sponsor ShareFEST 2013. The ShareFEST Conference will take place in Philadelphia, April 25-26 at the Loews Philadelphia Hotel. This conference is the only SharePoint conference focused exclusively on the use of SharePoint in the life sciences industry. More than thirty industry expert presentations are scheduled covering Implementation Tactics and Technologies as well and Case Studies & Enterprise Strategies. "USDM is excited to be a part of ShareFEST this year. Our expanded offerings for life science customers in…

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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