On-Demand Webinar
De Novo Classification Process
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..
Dealing with COVID-19 as an Employer: How to Manage in Crisis
This program will explore the impact of the virus both at work and for individuals. We will explore the laws created in response to COVID-19, the laws that apply to any pandemic or illness, laws applicable to layoffs and furloughs, policy considerations and other best practices. We will discuss what employers need to do to maintain a safe and functional environment. Our program also will dispel the myths, d..
Dealing with Difficult People
According to Deepak Chopra and Kabir Sehgal in a post for CNBC, one way to deal with difficult people is to not take what they say personally. If you do then you both get defensive and the situation escalates.This session shows you how to deal with the event, the situation, not the person. Position yourself as a cooperator, not a competitor, working together, not against each other. Gain some quick tips and..
Dealing with Employee Leave Abuse
Suppose one or more of your employees has taken a leave of absence, and your company or department is buckling under the added stress - and you suspect that one or more of those employees may be taking advantage, and may not really be in need of family or medical leave – or may even not be entitled to it. What if one or more of your employees ask for intermittent leave? Administration of continuous leave ca..
Dealing with the new overtime changes in the FLSA
The US Department of Labor has changed the salary level that an employee must earn in order to be considered exempt from being paid overtime. Although this was effective on January 1, 2020, if companies have not made this change they are accruing potential penalties until such time as the change is made and employees are correctly classified. If an employee is not eligible to be considered exempt then every..
Delay claims: Prevention and Management
Delay claims are part of project management, however, the way we deal with them can make a big difference. Delay claims cost money and time, as well as strain the relationship between the contracting parties. So it is better to take all precautions to prevent them from arising, and then learn a few hints to manage those that do happen, in the most effective way. This seminar will go over the definition of c..
Demystify Excel and Harness the Power Within
Excel spreadsheets have really become essential in the workplace. They are used for many purposes, from budgets to forecasts, from financial spreadsheets, to even more scientific purposes and everything in between. But, all spreadsheets require formulas and functions. Formulas are mathematical equations in Excel, and functions are built-in formulas. Building formulas is a crucial skill in Excel, one that ha..
Designing an Effective and Efficient Internal Audit Process for Your Quality Management System
This webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization. Areas CoveredUtilizing PDCA before your internal audits9.2.1 internal audit (general requirements)9.2.2 internal audit scope9.2.2 internal audit frequency9.2.2 internal audit methodsInternal Audi..
Designing and Using KPIs and Performance Dashboards
We need our leaders to be effective in deploying our resources and guiding our operations to reach our goals in the most effective way. We need everyone to understand our mission and strategy so we can be sure we are all pulling together in the right direction. How well do our dashboard reporting tools support your strategic mission and goals? Are they right timed and properly designed for the users? How ma..
Detecting and Preventing Accounts Payable Fraud
Accounts Payable (AP) is the one business function that, in many organizations, is more vulnerable to fraud than any other. That is because all funds that flow out of the organization must first pass through AP. And over time, dishonest insiders and vendors have created newer and craftier methods of stealing from organizations by exploiting control weaknesses in the AP function.Result: It is more important ..
Determining a Rational HPLC/UHPLC Selectivity Starting Point
Selectivity in a liquid chromatography (LC) separation is the ability to separate a molecule from other similarly structured compounds, such as conformational, positional, and optical isomers. Columns do this in a variety of ways that depend on the structural differences between the key target molecules. This is most commonly done by tailoring the column’s stationary phase so that the different target molec..
Developing an Effective CAPA Management and Root Cause Analysis System
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..
Developing an Effective Onboarding Program: The Key to New Hire Retention
Having a strategic onboarding plan in place can dramatically impact your business. Investing in an onboarding process will help reduce turnover and increase new hire effectiveness. An onboarding program isn’t just or more than a routine checklist; it should be a comprehensive process that makes the new employee, as well as the company, confident they made the right choice and confident they can succeed in t..
Developing Trust and Respect In the Workplace, Without Respect Work Environments Breakdown
Respect in the workplace is not just a good idea, but good for a company’s bottom line. Rude and disrespectful behaviors can create a dysfunctional workplace that pits people against each other, halts civil communications and destroys teamwork. Company culture becomes one of resentment and mistrust. When people can’t work together toward a common goal, the entire company suffers. If bad behaviors like these..
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..