The Press Release Resource

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs.  The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the Session: …

Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.  There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in …

SANTA CLARA, Calif., November 29, 2011 – eGestalt Technologies (www.eGestalt.com), a leading provider of cloud-based, SaaS-delivered, security and IT governance, risk management and compliance solutions for SMBs to enterprises, announced today that Jim Hare, VP of Worldwide Sales was named one of the Top 100 Executives in the Channel by CRN. This annual list salutes …

December 20, 2011 | Palo Alto, California: MetricStream Inc., the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced that a leading financial services provider has selected MetricStream GRC Platform for proactively managing risks, minimizing legal exposures, and ensuring compliance with policies and regulations surrounding customer interactions. The MetricStream solution will enable …

November 22nd 2011 – A free management application that allows businesses to measure, monitor and report on their compliance to PCI-DSS v2.0 payment card data security standards, has been launched by governance, risk and compliance (GRC) specialist Acuity. Available for download from the Acuity website, the compliance software monitors progress against the six milestones in …

Learn Whats Next Founder Dr. Jim Dragun Is The Title Sponsor Of High School Scholarship Contest Farmington Hills, MI, November 07, 2011 — Dr. Dragun a world-class scientist, entrepreneur and businessman founded and built a world-class engineering-science consulting company.  For over two decades, he has led a team of specialists in engineering, physics, industrial processes, …

Horizontech, Inc. (HTI), a Global information technology and document solutions company, today announced enhancements to its web-based Reporting platform for undeliverable mail. Danville, VA, Friday – September 09, 2011 – Horizontech, Inc. (HTI), a Global information technology and document solutions company, today announced enhancements to its web-based Reporting platform for undeliverable mail. HTI’s enhanced platform …

  September 07, 2011 | Palo Alto, California: MetricStream, the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced the release of the next version of its Risk Management solution which will empower organizations to proactively assess, manage and monitor varied organizational risks, including operational, financial, IT, security, regulatory, supply chain, reputation and enterprise risks. …

June 26, 2011 | Palo Alto, California: MetricStream Inc., the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced that its chairman, GunjanSinha, has been invited to speak at the 2011 Global India Business Meeting. Hosted by Horasis, the meeting will be held on 26-27 June, 2011 in Naples, Italy. Over 400 …

Bluefront Capital LLC announced the official release of the Custom Risk Marketing Tool. Specifically designed for startup and growing Hedge Funds without big risk management and IT departments, the custom risk management tool can help them clearly display risks and allow the prospective investors to test hypothetical allocations. By leveraging Custom Risk Marketing Tool’s functionality, …

eGestalt Technologies, today announced that Internal Medicine Associates of Memphis, TN has selected the company’s HIPAA solution, SecureGRC SB, to meet its compliance requirements. Santa Clara, CA, Thursday – June 23, 2011 — eGestalt Technologies ( http://www.eGestalt.com ), a leading provider of cloud-based, SaaS-delivered, security and information technology governance, risk management and compliance (IT-GRC) solutions …

June 20, 2011 | Palo Alto, California: MetricStream Inc., the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced its participation in the 17th Annual Gartner Security & Risk Management Summit which will be held on 20-23 June, 2011 in National Harbor, MD (Washington, D.C. Area). Featuring renowned industry experts and leading Gartner …

June 13, 2011 | Palo Alto, California: MetricStream Inc., the market leader in Enterprise Governance, Risk and Compliance (GRC) solutions, announced today that Peyman Mestchian, a leading industry analyst and Managing Partner at Chartis Research, will join Gaurav Kapoor, COO at MetricStream, in a webinar entitled ‘Best Practices in Operational Risk’. About the webinar As …

Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments …

May 18, 2011 | Palo Alto, California: MetricStream Inc., the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced its participation in the 2011 Internal Audit; Anti-Fraud; Compliance & Ethics; Privacy Conference. Hosted by the Blue Cross and Blue Shield Association, the conference will be held on May 16-19, 2011 in Lake …

eGestalt Technologies, today announced a White Paper that spells outin layman’s terms what businesses need to know about the Health Information Portability and Accountability Act (HIPAA). Santa Clara, CA, May  12, 2011 — eGestalt Technologies ( http://www.eGestalt.com ), a world leading provider of cloud-based, SaaS-delivered, security and information technology governance, risk management and compliance (IT-GRC) …

May 10, 2011 | Palo Alto, California: MetricStream Inc., the market leader in enterprise-wide Governance, Risk and Compliance (GRC) solutions, today announced its participation in the Super Strategies Conference and Expo 2011. Organized by MIS Training Institute, the conference will be held from 11th – 13th May, 2011 in Chicago, Illinois. GRC professionals from across …

Overview: This webinar will examine the existing and proposed requirements for the FDA’s DHF – including its derivative documents, the DMR and DHR. It will consider the MDD’s TF/DD requirements, and evaluate the documents’ differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and …

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s. Both USP <1225> and …

Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs …

Overview: If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in …

Overview: In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will …

Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule – there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how …

Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security …

13th April 2001 – Following the formal launch of the latest version of its BCM software, ClearView is delighted that its success has been recognised by being shortlisted in the prestigious CIR Awards in the Business Continuity Management Planning Software of the Year category. As a platform which is gaining market acclaim for its ease …

Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing …

Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application …

Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for …

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 …