FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. Why you should attend: Learn how to respond to FDA 483's and the best way to write the response. Learn the new policy from FDA regarding how and when to respond. Learn the best way to respond in...

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Why should you Attend: One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prep...

This webinar will provide an overview of NASA’s remote sensing data sets and products and describe how the data sets can be used to support utility monitoring, modeling, and management efforts. An overview will also cover satellites, instruments, and products related to climate and hydrologic conditions; watershed/land use characteristics; and source water quality. Successful applications of remote sensing data for water resources manage...

Many communities across the United States have deficient infrastructure systems and struggle with regulatory compliance issues. The American Water Works Association, in alliance with the American Society of Civil Engineers and Engineers Without Borders USA, has developed a program to fulfill such communities’ need for help in addressing these concerns. This program, the Community Engineering Corps® (CECorps), assists underserved US c...

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufac...

Gain an understanding of the legal basis for administrative orders and how the orders are used. EPA used to hold all of the cards when it issued an administrative order. A recipient could not challenge the factual or legal basis: it could either perform the remedy or wait for EPA to file an enforcement action and bring these challenges in the context of that action. Such a course had significant risks, because the penalties could be doubled fo...

This webinar will offer guided discussion on current and trending private financing tools, vehicles, and opportunities that public water utilities can potentially use to help meet infrastructure and operational financing needs. In addition to available private financing options that public and private water utilities of all sizes are using, discussion will focus on how choices to use various private financing tools can affect a utility’s...

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...

Many utilities are investing in AMI (Advanced Metering Infrastructure), however, no standards or published guidelines are available regarding customer leak notification. Some water utility managers are also concerned about loss of revenue and irritating customers. This webinar focuses on notifying metered customers of potential leaks or high usage through data generated with AMI. The establishment of thresholds for minimum leak volume or calcu...

Learn about what the future may hold for the 'Waters of the United States'. The land use development process requires the identification of Federal jurisdictional waters and wetlands on a project site or along a project corridor. The U.S. Environmental Protection Agency (USEPA) and the U.S. Army Corps of Engineers (USACE) published revised definition of ‘Waters of the United States' found at 40 CFR Part 230, on June 29, 2015, effective A...