FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and practical recommendations on how to respond to…

The World Health Care Congress Middle East, co-sponsored by the Health Authority and the Tourism Authority of Abu Dhabi, is the most prestigious health care, convening more than 500 global thought leaders and key decision-makers from all sectors of health care to share global best practices. The 2010 Congress will take place 5-7, December 2010, Abu Dhabi, UAE. The Congress will feature the top industry influencers, including health ministers, leading government officials, hospital directors, IT innovations, pharmaceutical and medical device companies and health care industry suppliers. Register by December 5 and save $200 when you call World Congress at 800-767-9499…

The 6th Annual World Healthcare Innovation and Technology Congress (WHIT v.6.0) is the leading event for senior executives tasked with making multi-million dollar strategic, organizational and IT decisions to position their organizations for success in the rapidly changing marketplace. WHIT v.6.0 brings together providers, payers, government officials and other key stakeholders to provide critical insight and leading-edge case studies on innovative technologies and strategies that will improve outcomes and minimize costs. ** Confirmed speakers include FIVE speakers whose organizations have reached Stage 6 or above on the HIMSS EMR Adoption Model(sm) and SIX speakers from H&HN's 2009 Health Care's 100…

The 6th Annual Employer Health, Human Capital & Wellness Congress convenes 400+ CEOs and senior level financial, HR, and benefits executives from major Fortune 1,000 employers to share successful initiatives and real solutions for reducing the burden of healthcare costs. The goal is for delegates to leave with an action plan to capitalize on the measurable business value of healthcare benefits and innovation in wellness and prevention to increase employee engagement and performance. This year is especially critical as employers prepare for the transformation of the healthcare delivery system. Register By February 1 and save $200 when you call World…

As the leading European event on health care business innovation, The 7th Annual World Health Care Congress—Europe is the only major international forum that convenes over 500 leaders from all sectors of health care to share the best practices and successful initiatives for improved delivery and outcomes in Europe. The 2011 Congress will feature the top industry influencers including health ministers, leading government officials, hospital directors, IT innovators, decision makers from public and private insurance funds, pharmaceutical and medical device companies, and health care industry suppliers. Register by April 13, 2011 and save $200 when you call World Congress at…

The 8th Annual World Health Care Congress (WHCC) is World Congress' flagship event in which over 1,800 health care, government and corporate leaders formulate solutions to the challenges of health care cost, quality and delivery. In response to demands from the nation’s largest providers, payers and employers, the 8th Annual WHCC convenes the major sectors in health care to determine actionable goals and implementation strategies to demonstrate quality, consumer choice, cost-effectiveness and transparency. Thought leaders engage in debates, present case studies and share best practices from all industry sectors including leading employers, CMS officials, insurers/payers, health system and hospital providers,…

The New Islamic Public Sphere Programme invites proposals for papers at the Conference on "Re-enchantment of Arab Television: Audience responses and identity constructions" to be held in Copenhagen, 27 – 29 May 2011 The main issue of this conference is how Arab audiences respond to religion and religious programming on Arab television. A focus on Islamic programming is particularly requested, but also papers on audience responses to other religious programming are encouraged. In spite of the common recognition that the effect of media has to be understood in the encounter between media discourse and audience responses, very often the Arab…

The Organization of Islamic Conference in Cooperation with the American Islamic College presents: Conference on “Islam and Muslims in America” Agenda 28 September, Tuesday 7:00 pm*Grand opening of the Dormitory and the Auditorium of the College* with Keynote Address by Secretary General of the OIC H.E. Dr. Ekmeleddin Ihsanoglu 29 September, Wednesday 8:30 am Registration 9:00 am Welcoming Speech: Dr. H. Ali Yurtsever, American Islamic College 9:10 am Protocol Speeches 10:00 am 1st Panel: The Role of the OIC & The Scope for its Relations with American Muslims Moderator: Mr. Ahmed Rehab, Executive Director of CAIR-Chicago Amb. Ufuk Gokcen, Ambassador…

The objective of this Conference is to bring together researchers from both academia and industry under one roof, to discuss and to share the latest developments in the field of nanotechnology MAJOR TOPICS Nanomaterials including Nanoparticles, Nanocrystals , Nano-porous materials, 2 Nanomechanics, Nanotribology, Nanocomposites, Nanoelectronics, Nano-Magnetics, & Quantum Computing, Nanobiotechnology , Nanomedicine, Nanotubes/Nanowires/Quantum Dots, NEMs, MEMs, Nano-Fluidics, Nano-Actuators, Nano-Sensors, Nano-robotics, 7 Nano-Fabrication, Nano-Lithography, Nanotechnology for Energy (fuel cell, solar cell, hydrogen storage), Other related topics CALL FOR PAPERS The organizing committee invites original research papers for Oral/Poster presentation. Authors are requested to submit an abstract of their work in about…

Conference name: 13th International Conference on Enterprise Information Systems (ICEIS) Venue: Beijing, China Event Date: 8 - 11, June 2011 Scope The purpose of the 13th International Conference on Enterprise Information Systems (ICEIS) is to bring together researchers, engineers and practitioners interested in the advances and business applications of information systems. Five simultaneous tracks will be held, covering different aspects of Enterprise Information Systems Applications, including Enterprise Database Technology, Systems Integration, Artificial Intelligence, Decision Support Systems, Information Systems Analysis and Specification, Internet Computing, Electronic Commerce and Human Factors. ICEIS focuses on real world applications; therefore authors should highlight the benefits…

The First International Conference on e-Technologies and Networks for Development (ICeND2011) The Institute of Finance Management (IFM) Dar-es-Salaam, Tanzania Aug. 3-5, 2011 http://www.sdiwc.net/tn/index.php All the papers will be reviewed and the accepted papers in the conference will be published in the “Communications in Computer and Information Science” (CCIS) of Springer Lecture Notes Series (www.springer.com/series/7899), and will be indexed in many global databases including ISI Proceedings and Scopus. In addition, selected papers after complete modification and revision will be published in the special issues journals. ======================================================================================= The proposed conference on the above theme will be held at The Institute of Finance…

Check-in Asia is the passenger and baggage processing forum for airlines, airports and other travel industry stakeholders across the Asia Pacific region to debate how airport facilities should be developed to accommodate new check-in process and technology to improving the whole passenger experience. Check in Asia technology conference will be covering industry technologies such as CUPPS, Mobile Phone Check-in, Web-based Check-in, Biometric Check-in, passenger bag drop and NFC (Near Field Communications), etc.

ATC Global is the world’s premier meeting place for the international Air Traffic Management community. The potential to expand business contacts and meet face to face with global industry colleagues, customers & suppliers is immense, with almost 5,000 industry professionals from 96 countries attending across 3 days. The 21st annual ATC Global Exhibition & Conference will take place 8 – 11 March 2011. The event which comprises a three day exhibition and two day conference and over 30 free to attend seminars, has the full backing from a range of influential organisations such as CANSO & Eurocontrol. For more information…

The EFV is the federation of national premanufactured building associations in Europe. Today the federation consists of the eight national members Austria, Bulgaria, Germany, Great Britain, Hungary, Ireland, Sweden and Switzerland. This year Bulgaria and Bulgarian Association of Premanufactured Building have the honour to be a host to EFV Annual Meeting. The main topics will be: - education; - earth quake safety; - fire resistance; - eurocodes; - sustainability. For more information: http://cim.bg/index.php/en/view/organizing-annual-meeting-EFV

The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and…

This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe. Why should you attend: Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The regulatory framework in Europe presents complex challenges to meeting international requirements effectively. Areas Covered in the Session: * International Conference on Harmonization (ICH) * Regulatory Framework * European Medicines Evaluation Agency (EMEA) * Eudravigilance * Electronic submission of ICSRs…

The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data compliance given the impacts on your IT department. Why Should You Attend: The HITECH Act was one of dozens of provisions tucked into the economic stimulus package, known as the American Recovery and Reinvestment Act, in February 2009.…

This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them * Better communication on risks to stakeholders * Measurement criteria on GRC actions and a basis for ongoing improvement What You will Learn from the Webinar: * Receive a clear picture of the current view of GRC * Obtain a clear knowledge of SLA concepts…

Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions…

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system. Areas Covered in the Session: *…