Based on the previous success of generation asset management & maintenance events in North America, the 2nd Annual Hydro Plant Maintenance & Reliability Conference seeks to provide the hydro generation industry with effective maintenance strategies to integrate into their current programs and to aid in budget restraints. Key Topics to be Covered Include at the 2012 Conference: -Discover ways to preserve hydro generation assets through life cycle management strategies -Discuss strategies to maintain plants while addressing budget issues -Enhance maintenance processes throughout all aspects of operations -Improve maintenance strategies to increase lifecycle and reliability -Understand common issues that impact the…

The Hydro Licensing & Compliance Forum will focus on mitigating licensing costs and compliance risks by establishing an effective internal and external communication protocol and utilizing monitoring strategies and automating a costly and lengthy licensing process. By attending you will learn best practices for expediting the licensing process and implementing a strong compliance program. This event will bring together Heads of Licensing, Compliance, Environmental Affairs, Regulatory Affairs, Legal Counsel and similar to discuss the most pertinent issues including but not limited to: -Manage FERC’s authority under Parts II and III of the Federal Power Act (FPA) -Enhance compliance strategies to…

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10. Why should you Attend: Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to Quality Systems in the pharmaceutical industry. This seminar…

Now in its 2nd year, the Mining Americas Summit is the premier networking event of 2012. Senior executive leadership will gather to discuss the capital management strategies, cutting edge technologies and operational investments that will drive the mining industry for years to come. It's an exciting period of opportunity and investment in the sector. Be part of the discussion that leads to take-home solutions to current critical challenges facing your resource projects. Establish the direction and vision for your company using the latest information from top industry performers as they will aid your efforts in: - Adopting leading policies and…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use…

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be…

This 90-minute webinar will review the 21 basic elements that need to be addressed in the traditional 510(k) submission, as required by the FDA. Why Should You Attend:- The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do proactively to address these concerns and better ensure a smoother review…

The 6th International Conference on Pedestrian and Evacuation Dynamics will be held from June 6th to June 8th 2012 at the Institute for Transport Planning and Systems (IVT) of the Swiss Federal Institute of Technology Zurich (ETHZ). Prof. Dr. Ulrich Weidmann, Uwe Kirsch (both ETHZ) and Prof. Dr. Michael Schreckenberg from the University of Duisburg-Essen (UDE) are going to be the hosts of this event. Confirmed keynote speakers Uwe Hanebeck Karlsruhe Institute of Technology "Multimodal Extended Range Telepresence in Pedestrian Simulation" Paul I. Weinmann ICTS Europe, Amsterdam "Behavior Assessment of Individuals in Crowds - a View from the Perspective of…

ICCITEE 2012 provides a forum for researchers who study technology enhanced learning to publish research findings and exchange experiences in conducting related projects.

Please join The Clute Institute for our 2012 Rome European Academic Conference, June 6-8, 2012 convening at the NH Leonardo Da Vinci located in Rome, Italy. We offer four tracks at this conference: Business & Economics, Education, Engineering Education, and Health Sciences. The Business & Economics track provides a forum for faculty to present their research on any accounting, CIS/CMS, economics, finance, management, marketing, related teaching, or other business-related topics. The Education track provides a forum for faculty and administrators to share proven and innovative methods in teaching at all levels of education. All teaching or academic related topics are…

Transforming the Business through Integrating SWP June 6-8, 2012 // W Hotel Chicago City Center // Chicago, Illinois TMA’s 2012 Workforce Planning Conference will concentrate on Transforming the Business through Workforce Planning. Rather than focus on the different components of WFP individually as silo topics, examples being partnering with the business, role segmentation, scenario planning, we will offer up case study after case study that tell of different approaches where SWP has impacted the business successfully as it is changing, highlighting the differing emphasis within each. Group Discounts Register 3 or more attendees and save! 3 to 5 attendees –…

Antibody drugs play a more and more significant role in biopharmaceutical industry around the world. Over $50 billion dollars sales in the world market, it keeps a rapid growth with the speed over 20 percent per year. The ballooning of antibody shows that: with the rapid development of science and technology, antibody must be the hot in the next decade. With the profound influence of previous Pharma manufacturing summit, based in Shanghai China Antibody China Summit 2012 is about to become one of the most influential international summit. We would like to be committed to the prosperity of industry and…

Please join The Clute Institute for our 2012 Rome European Academic Conference, June 6-8, 2012 convening at the NH Leonardo Da Vinci located in Rome, Italy with tracks in Business & Economics, Education, Engineering Education, & Health Sciences. The Business & Economics track provides a forum for faculty to present their research on any accounting, CIS/CMS, economics, finance, management, marketing, related teaching, or other business-related topics. The Education track provides a forum for faculty and administrators to share proven and innovative methods in teaching at all levels of education. All teaching or academic related topics are welcome, such as teaching…

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Why Should You Attend:- Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device.…

Overview: The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. ISO 13485 covers the rest of the world. The webinar describes management responsibility by reviewing the regulations and the reasoning that FDA published. Management responsibility, in QSR, has five major components: Quality Policy, Organization, Management Review, Quality Planning, and Quality System Procedures. The webinar covers each of these topics and provides a list of things you should consider in your implementation. Why should you attend: One of the most common areas for FDA Warning Letters is Management Responsibility.…

Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that…

The second edition of the International Conference “The Future of Education” will take place in Florence on 7 - 8 June 2012. The aim of the Future of Education Conference is to promote the sharing of good practice and transnational cooperation in the field of the application of innovative education and training strategies, methodologies and solutions. The Future of Education conference will also be an excellent opportunity for the presentation of previous and current projects and innovative initiatives in the field of education. Teachers and experts in the field of education as well as trainers and coordinators of educational projects…

The 3rd annual TMT Finance & Investment Africa Conference will bring the leading telecom executives, financiers and advisers to London again at an exceptional time for Africa’s communications industry. This year’s conference will include sessions on Telecom Leadership Strategies, Financing Growth, Regulation and Stimulating Investment, Mergers and Acquisitions, Infrastructure Ownership and Towers, and Investing in New Technology including Wimax, LTE, 4G, High Speed Broadband and Mobile Money. Join the leading CEOs, CFOs, Investment Bankers, Thought Leaders and Specialist Advisers at this influential high level strategy event. www.tmtfinance.com/africa