Cost Justification: What is Your Organization’s Sigma LevelSigma Level versus dollars lost as a percent of sales is explained. By understanding your processes sigma and addressing risk properly your organization will benefit considerably. Improvement Team Selection The success of quality improvement projects will come down to the quality of the team members working on the project. Responsibilities of P..
Annually wage and hour mistakes cost companies in the United States millions of dollars in back pay and fines. With the increased scrutiny companies are under by the U.S. Department of Labor and the increased aggressiveness being shown it is important for companies to understand the Fair Labor Standards Act in greater detail. Company managers and human resources professionals need to understand the top five..
The passage of the 21st Century Cures Act and the recent release of draft guidance from FDA signal changes ahead for the Humanitarian Use Device and Humanitarian Device Exemption Programs in the US.Whether you work strictly with medical devices, or with device combination products you will not want to miss the opportunities afforded by these changes. The requirements for qualifying for Humanitarian Use Devi..
The title Letter of Intent is oft-used but frequently misunderstood with troubling consequences those sending and those receiving. Such troubling consequences often arise because there is confusion in the business, professional, NGO and legal communities about what the term really means; which is that a true Letter of Intent’s enforceability and legal effect are a hybrid between a pure fully enforceable con..
Bankers rely on cash flow as the primary source of repayment, but collateral and guarantors offer the plan B solution to repayment when Plan A’s cash flow doesn’t work. Areas CoveredIdentification of possible collateral assetsDescription of collateral valuation factors—liquidity, marketability, security options, and typical LTV’sEvaluation of guarantor financial statements to determine adjusted net wo..
Gender identity refers to the gender with which a person identifies, which may be different from that person’s assigned or anatomical gender at birth. While no federal law expressly prohibits gender identity discrimination, the Equal Employment Opportunity Commission (EEOC) interprets federal law’s prohibition against “sex” discrimination to include gender identity discrimination. And, around 20 states and ..
Mr. Yuval Shapiro shall review the basic statistics that is behind the Sample Size selection. Explanations on how to select samples for Design (verification and validation) phase, and for Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorities require..
Behavioral-based interviewing allows you to see patterns that are often missed when people are answering basic questions. You can get past what a candidate says and focus on how they respond. Using different types of interview questions will help you determine which people are best suited to fill positions in your organization.According to a three-year study conducted by Washington, D.C.-based Leadership IQ..
Trust is your key to opening the doors of opportunity for you.Trust is created by everything we do and say. Our reputation and careers are built on it.The big question to ask yourself is: Are you trustworthy?Discover the real power behind Trust that accelerates engagement, fosters productivity and supports your company’s community reputation. Trust is everything in the business world today. It is all about ..
Tax laws change, IRS provides guidance on several topics throughout the year and Tax Court provides new interpretations of the tax law. This happens every single year and practitioners, businesses and individuals need to keep up to date on all of these changes.This webinar will look at the most important changes throughout the year. For example, after April 15, the IRS came out with Frequently Asked Questio..
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..
Your elevator pitch is an invitation to get to know you, what you do and to discover any possible connections. Sadly, most people, whether a novice employee, a beginning entrepreneur, or a seasoned corporate executive, do not know how to present themselves well and are losing prospective clients and relationships as a result. Don’t be “most people;” understand how to make the most of those first important o..
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device se..
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical hold. What’s more; the options/ ways to respond to the clinical hold is also discussed to help the sponsor effectively work toward the resolution on t..
Sales are really a competition. It's about who can get the most done and who can close the sale -- in a very, very tough environment.Regardless of what you sell odds are you have many competitors that are calling on the same customers. To make it even more difficult not only are you competing against your direct competitors but you're competing against other uses of money and resources within your customer'..