The Press Release Resource

Overview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case …

Overview: This webinar will provide valuable assistance and guidance to device companies in involved in labeling changes. FDA recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via …

Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S: “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance …

Different governments in South East Asia have different policies, but Minoru Kaneko, Singapore Chief Representative for NEXI, predicts that South East Asia\’s economic growth will continue for the next 5 years and economic growth will continue to prompt infrastructure development. “The Vietnamese government is deeply involved in infrastructure development. That is not a bad thing. …

Prague, Czech Republic, March 14, 2011 – Skrivanek Language Solutions, a translation company dedicated to serving the language translation needs of large and small clients for over 17 years, announced its participation in the GALA 2011 Conference in Lisbon, Portugal on March 28-30, 2011. At this year’s GALA Conference Skrivanek Executive Manager in Germany & …

Overview: This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered.  Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and …

Overview: This webinar will cover several recommendations to improve the hospital’s Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: DEA …

Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. The …

Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed …

Overview: This presentation will explore FDA Corrective Action and Preventive Action findings in medical device manufacturer quality systems to determine FDA’s concerns. The FDA and ISO 13485 requirements for CAPA will be reviewed to identify how procedures may define a compliant CAPA system. Implementation and maintenance of the CAPA system will be explored. FDA indicates …

eGestalt Technologies Inc., today announced its SecureGRC application was voted as a runner-up in the Managed Services Category at the Xchange Tech Innovators November 10-12 event in Las Vegas. Santa Clara, CA, November 29, 2010 — eGestalt Technologies Inc. ( http://www.eGestalt.com ), a provider of IT security and governance, risk management and compliance (IT-GRC) solutions …

The landscape of trade and export has been changed dramatically over the past two years. The world’s merchandise exports fell 23% to $12.15 trillion in 2009 after the global economic downturn, while world commercial services exports declined 13% to $3.31 trillion. Asia is less affected by the Global Financial Crisis then other regions, Asian exports …

September 13 2010 – Hitachi Consulting UK today announced that it has implemented a new risk management and claims process and handling system on behalf of the Co-operative Group Risk and Insurance Department (GRID). Known internally as, the GRID @Risk Project, the new strategic platform, based on Microsoft SharePoint, is designed to enable the company …

Technology and Business model innovation enables adoption of IT-GRC solution by every Enterprise. Santa Clara, CA, June 04, 2010 – eGestalt Inc. ( http://www.eGestalt.com ), a provider of information technology governance, risk management and compliance (IT-GRC) solutions for all enterprises, including small to mid-size organizations, today announced the U.S. availability of SecureGRC™, a patent-pending online …

20 April 2010: The Information Security Forum (ISF) is extending its world-renowned membership programme to help SMEs address an increasing number of IT security threats, including the fight against cybercrime, protecting customer data and the growth of social networking. This new ISF Membership, for companies with turnover of less than £100m, recognises that SMEs face …

April 8 2010 – Lorica has set up an Actuarial and Risk Management division to give employers advice and support on how to manage, reduce or eradicate the risks associated with operating Defined Benefit (DB) pension schemes and other trust based arrangements. Sean Gilfeather, who has joined Lorica to head its newly established Actuarial team …

Innovator of Unified Block and File Storage Enjoys Strong New Customer Traction Facilitated by Channel Partners and Strategic Focus on Enabling Customers to Consolidate, Virtualize and Protect Rapidly Growing Business Data PARSIPPANY, New Jersey – January 5, 2010 – RELDATA Inc. (www.reldata.com), the innovation leader in unified block and file storage solutions over iSCSI, announced …

Leading GRC Provider Ends 2009 with Strong Customer Acquisitions, Impressive Partnerships, and Significant Technical Accomplishments SAN JOSE, Calif., January 5, 2010 – Agiliance Inc., the leading independent provider of integrated Governance, Risk and Compliance (GRC) solutions, today announced it has achieved record financial performance with year-over-year revenue increasing more than 100% in 2009. Driving company …

Agiliance to Host Privacy Management Webinar