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IEC 62304 for Medical Device Software
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..
IFRS Converting Your Cash Flow Statement
One step in switching over to IFRS is to convert your cash flow statement. In this presentation, we will work through the entire cash flow statement. We will review in detail exactly what changes will need to be made to comply with these rules. This session will enable you to successfully convert your cash flow statement.Areas Covered How net income will changeNon-cash items that affect t..
Impact Of Federal Reserve Policy: Now And Ahead
In today’s fast-changing world financial environment plays a crucial role in influencing economic growth, investments, employment, external trade, inflation, interest rates, credit demand and supply, exchange rates, purchasing power, consumer spending, Government Budget, and also your wealth, investment, financial planning, and economic wellbeing. It is, therefore, imperative to understand how the policy of..
Implementing a Project Management Culture
As organizations strengthen and mature, the gap between the business objectives and technical solutions tends to widen, the knowledge and skill sets become more specific (and different).Project Management is a strong bridge between these teams. It may not be an objective to become a "Project Manager" yet every employee in your organization does project management - completing a defined task by a certain tim..
Implementing a Quality Management System
The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and responsibilities, useful metrics, and tools to monitor performance, and useful documentation will be given.Learning ObjectivesGLP RegulationsQuality Management System (QMS)DefinitionPrinciplesPurposeFunctionE..
Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to ..
Improve Your IRS Compliance: Use Best Practices for TIN Solicitation
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..
Increasing Criminal Risks of Intermediaries for Cross-Border Financial Crimes
In the last couple of decades, the world has experienced growing prosecutions of intermediaries for cross-border financial crimes. A U.S. bank was convicted by a Spanish court for moving money in the Pinochet criminal investigation instead of freezing it. The U.S. and State of New York have brought criminal cases against banks for a variety of financial crimes, especially economic sanctions. The U.S. DOJ ha..
Independent Contractors: Issues, Practices, and Steps to Successfully and Legally Staff Your Company
Companies meet their staffing needs by using a variety of arrangements. Besides the hiring of traditional employees, employers can use contingent employees such as temporary employees, seasonal employees, and leased workers hired through temporary staffing agencies. A growing number of companies are leveraging independent contractors, especially because a larger percentage of the workforce is preferencing "..
Information Cyber Security Planning for Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities
Information Cyber Security Planning for Governance, Risk and Compliance (GRC) is essential in this world of new technologies, cyber events, natural and manmade disasters. GRC refers to a company's coordinated strategy for managing the broad issues of corporate governance, enterprise risk management (ERM) and corporate compliance with regard to regulatory requirementsEnterprise IT Governance, Risk, Complianc..
Internal Audit for Medical Device Companies
Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your i..
International Asset Recovery
Any fraud or debt collection over a few million dollars will have international components. The fraudster/debtors use the ease of moving to different countries to create distance resistance. The money they have taken is much more resistant to your efforts to collect the money. There is a number of tactics employed by the fraudsters to frustrate and impede any collection. What is needed is a well-honed and c..
Interviewing Skills for Managers and Supervisors
The everything-you-need-to-know-before-you-say “you’re hired” seminar!Nothing’s scarier than the thought of making the wrong hiring decision. After all, it means throwing away a substantial investment of time and money on recruitment, training and benefits.This fundamental seminar is your ticket to make the right hiring decisions and contribute more to the company bottom line.Areas CoveredMaking the selecti..
Introduction to Sales and Use Taxation
Sales tax? Use tax? What’s the difference? Must I charge tax on my internet sales? Will I owe taxes in more than one state for the same sale? Why is my drop shipper charging me tax? Why did I receive a NEXUS Questionnaire and what if I don’t respond to it? I just received a notice that I have to conduct a self-audit and report my findings to the state – is this for real? I need help!Over 40% of state budget..
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?
The EU MDR 745/2017 is a complete game-changer to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show, how to conduct a gap analysis, an action plan and how to be on track until May 2020. Learn, what to do into the quality management department and what to do in the regulatory affairs..