The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to...

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments. Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceu...

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes: Design and TPP Pre-clinical testing and comparability Clinical testing Analytical studies Stability of biosimilar products Why you should attend: The regulation of Biosimilars is very complex and the approach used by various regions differs. Professi...

The West Coast Energy Management Congress (EMC) is the largest energy conference and technology expo held on the U.S. West specifically for business, industrial and institutional energy users. It brings together the top experts in all areas of the field to help you set a clear, optimum path to energy efficiency, facility optimization and sustainability, as well as innovation solutions to improve your ROI. You can explore promising new technolo...

Congregation to endow, enrich and foster the knowledge hunters in the Polymer World. Conference series LLC takes immense delight in announcing the 2nd World Congress on Polymer Science and Engineering” during May 8-9, 2017, in Barcelona, Spain with the theme of “Showcasing Polymer Science and Engineering breakthroughs universally”. Every day, an individual comes into contact with hundreds, if not thousands, of plastics (most...

Energy, Power & Facility Management Strategies & Technologies 2017Decision makers from business, industry and government must now seek integrated energy solutions — solutions which assure both a secure and affordable power supply, and effective management of both energy and overall operational costs. Globalcon, presented by the Association of Energy Engineers, is designed specifically to facilitate those who need to get up to spe...

We invite you to be a part of the nation's largest, most active buying venue for end user energy products and services – the World Energy Engineering Congress (WEEC). There's no better opportunity for your sales team to directly reach thousands of top energy management decision makers from throughout the U.S. and abroad. The WEEC expo is attended each year by the nation's leading energy professionals in business, industry, and government...

The design and construction of a laboratory, regardless of its use, involves many stakeholders. While providing a safe environment for laboratory users to perform their work is imperative, competing stakeholders’ needs often cause health and safety considerations to be overlooked. Participating in Guidelines for Laboratory Design: Health and Safety Considerations will help you address this issue by providing you with an understanding of...

The West Coast Energy Management Congress (EMC) is the largest energy conference and technology expo held on the U.S. West specifically for business, industrial and institutional energy users. It brings together the top experts in all areas of the field to help you set a clear, optimum path to energy efficiency, facility optimization and sustainability, as well as innovation solutions to improve your ROI. You can explore promising new technolo...