Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required the number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test...
This webinar will introduce attendees to the foundations of statistical process control (SPC), including the effects of variation and accuracy on process quality. The definition of a Six Sigma process will be illustrated. Attendees will learn how to construct SPC charts that provide visual controls (easily understood signals) that tell production workers when the process requires adjustment to prevent the m..
This webinar discusses the genesis of RFIs, their development in the industry and frequent common use. The webinar discusses the impact of RFIs on construction projects, drawing upon data provided by a global construction software provider and other studies to assess how RFIs and the RFI process impact both small and large scale construction projects. The webinar addresses the abuse of the RFI process exami..
Much has been written over the years about proving and pricing contractor claims on construction projects. But little has been published about or presented on subcontractor delay claims. Do subcontractors have the same rights and remedies as the prime contractor? Are they held to the same standards? What are their legal rights? Do owners owe time extensions for subcontractor delays? Are prime contractors at..
Failure mode effects analysis (FMEA) and the control plan are both parts of advanced quality planning (AQP). FMEA, in fact, defines the control points or critical nodes of the control plan; process activities that must be controlled to ensure conformance of the critical to quality (CTQ) product characteristics. The dynamic control plan is a natural combination of the process FMEA and control plan into a sin..
Financial institutions most often inherit some implicit view on their risks and then add elements as time goes by, as mishaps occur and as regulators demand. The result is all too often the spectacle of a claim at consistency, whilst risk priorities are more the result of interdepartmental relationships, and some risks can be misunderstood. However, when setting up a complete framework, pitfalls are legion...
Project partnering is one of the most effective tools in the construction management process employed to deliver successful projects -- projects that complete on time, in the budget, safely, with the specified quality and have no outstanding disputes at the end of the job. Construction Managers are frequently the leaders in convincing owners to adopt project partnering and must be involved in the entire pro..
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management. Present some common errors when dealing with risk management. Present the new additions and changes to the new standard. Risk approach has become a mandatory practice during the Product Realization of Medical Devices. This p..
Having a solid understanding of applicable regulations is not only legally required, but it can also offer your company tactical and strategic advantages. Preventing fines, penalties, and potential loss of import privileges will keep your business running smoothly, efficiently, and at the lowest cost of operation. Knowing, understanding, and applying the subtle areas of trade compliance and global trade man..
This IRS regulatory compliance training will explain the Best TIN Solicitation Best Practices. While TIN solicitation might sound too lascivious for the legitimate business world, it is critical that every organization take this task seriously. For if they don't, a very uncomfortable and costly audit with the IRS is likely to ensue.Areas CoveredIdentify all required TIN information you need to collectDesign..
The new rule is highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated food choices based on science, in short session encapsulates everything industry needs to know on launching the (NBFDSA).Learning Objectives Background on US GMO (Genetically Modified Organism) LabelingBas..
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 occurrenc..
US Customs law dates back to 1879 and was far less burdensome, legally, on the US importer until 1993. Under current law, the US Customs Modernization Act, the US Importer is now mainly responsible for adherence to all US Customs laws and regulations. While Customs calls it a “shared responsibility”, the burden is on the importer to “exercise reasonable care”. In this session, we’ll discuss the basics of a ..
The concept of Enterprise Risk Management as a strategically-aligned, portfolio management approach to risk management was first proposed nearly 30 years ago. This session will briefly discuss the history of ERM, clarify the distinction between ERM and risk management, and discuss the value that ERM brings to any complex organization. Key steps in implementing and maturing an ERM program will be covered.Are..
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..