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..
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua..
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..
Learn practical contracting do’s and don’ts from an experienced litigator. This webinar will discuss keys to pre-contract diligence, negotiating key terms, and vague performance language. The listener will also learn what to do when the relationship sours and the dispute seems headed for litigation.Areas CoveredKey issues to address in the contract, including: ◦ Payment terms ◦..
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..
Whether you are new to the construction practice or are looking for a comprehensive refresher, this course will cover multiple issues that must be taken into consideration in the realm of construction law. Join our experienced faculty as they cover a broad, basic overview of the construction process; the fundamentals of construction contracts and key provisions; the basics of insurance; and the impact chang..
Best Practices for Using Your Quality Management System’s Quality Objectives and KPIs for Meaningful Process Improvement
Numbers, data, facts, perfect information all allow us to make more informed less risky decisions in every aspect of our lives. Due to the increased demands and business pressures to do more with fewer resources, decision-makers in every organization are tasked with making fast and informed decisions.Knowing how what to measure, how to measure it, what the data says where you are now, where you want to be i..
This webinar will show how to use ANSI/ASQ Z1.9 (formerly MIL-STD 414) to define sampling plans for products with continuous-scale (variables) data, and use the accompanying switching rules to move between normal, reduced, and tightened inspection as required by the publication.ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a widely accepted standard for sampling by variables (continuous scale measurements). The s..
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. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..
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..