Traininng.com LLC Claim

Course Description

Overview Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. Why should you Attend This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry. Areas Covered in the Session Background on Human Error Phenomena Importance of Human Error Prevention/reduction Training and human error Facts about human error Human Error as the Root Cause What is Human Error How is Human Error controlled? Common mistakes Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness Types of error Human error rates and measurement Trending and tracking Prediction CAPA effectiveness Learning Objectives: Understand human error: factors and causes Understand the importance: regulatory and business Define the process to manage Human Error deviations Identify Root Causes associated to human error deviations Learn how to measure human error rates at your site Identify what I can do to support human reliability Who Will Benefit Training Managers and Coordinators Operations Manufacturing Plant Engineering QA/QC Staff Process Excellence/Improvement Professionals Industrial/Process Engineers Compliance Officers Regulatory/Legislative Affairs Professionals General/Corporate Counsel Speaker Profile Ginette Collazo , PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics. https://www.traininng.com/webinar/controlling-human-error-in-the-manufacturing-floor-200159live

Course Fee

$150

Course Fee

$150

Course Name

FDA's New Import Program for 2018 - Traininng.com

Course Description

Overview The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose. Why should you Attend The new import entry filing requirements became effective in 2016 and are posing problems for user. Failure to provide the correct information creates costly delays and, in some cases, the frustrating task of contacting the FDA to resolve the problem. FDA's software screening program, PREDICT, and U.S. Custom's ACE program require careful attention. Errors will cost money. The less obvious software is the FDA's and U.S. Custom's linking of your legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. That sets up how FDA will apply its requirements. In addition, the information on the manifest, invoice and affirmation of compliance make importing easy provided you get it right. Making errors means FDA may flag you as a problem that requires greater scrutiny for data verification. As if delays and detentions are not bad enough, there will be punitive fines for filing incorrect entry data in ACE. This is a needless cost as long as you understand what you should be doing. The benefits require the correct information for FDA and U.S. Customs software programs. At least now, using the PREDICT and ACE programs let you check the status of your entry and what the communications are between your broker and U.S. Customs. There is a lot of information at your fingertips now, if you get it right. Areas Covered in the Session FDA's required information for the PREDICT software screening prior to entry FDA product codes Custom's required information for the ACE software system prior to entry Custom's Harmonized Tariff Schedule (HTS) Affirmation of Compliance (AOC) Who Will Benefit Business Planning Executives Regulatory Managers In-house Legal Counsel and Contract Specialists Venture Capitalists Business Acquisition Executives Owners of New or Developing Import/Export Firms International Trade Managers Import Brokers Investors Logistics Managers Sales Managers Speaker Profile Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University. https://www.traininng.com/webinar/fda's-new-import-program-for-2018-200162live

Education level

Professional

Education Subject

Project Management, Health and Safety, Design, Engineering, IT and Computer Science, Health and Medicine, Accounting and Finance, Education and Teaching, Hospitality and Tourism

Payment Option

Online Payment