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Showing posts with the label ADAAA

Medical Device Change Control and FDA Submissions

This course is intended to provide an overview of 2 new  FDA draft guidance documents  that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device. The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k). The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. In this webinar expert speaker Carolyn Troiano will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject...

Fair Housing: Reasonable Accommodations

Reasonable accommodation is one of fair housing’s “hot topics”. This typically accounts for over 50% of the fair housing complaints to HUD in the past year. Reasonable accommodations can be requested during the application process, during tenancy and during an eviction. It is important to learn the correct procedure to ask for, review and implement this important action. Reasonable accommodations are requested because of a disability of either physical or mental issues. It is important that one understand the definition of disability and when it come into play to allow a disabled person to enjoy the same quality of life as an non-disabled individual.  In this webinar expert speaker Paul Flogstad will explore the misunderstandings and best practices of particular relevance to small employers when accommodating employees with disabilities in and around the workplace.  Session Highlights:  Definition of reasonable accommodation  Definition of disa...

Handling Multi-State Payroll Taxation

Understanding how to calculate tax for employees in 2 or more states can be confusing. Plus what state laws for payroll need to be followed when employing employees in more than one state.  It is essential for payroll professionals to calculate flawless payrolls to avoid any litigation by state payroll tax auditors. Join us, in this webinar by expert Dayna Reum, who will explain the right measures in complying with various payroll laws and determine tax guidelines for employees who live and work in different states. You will benefit by learning to calculate payroll for employees who work in multiple states by getting updated about how other state laws can affect payroll calculations.  Session Highlights:  Residency  Reciprocity Agreements  Resident/Non-Resident Withholding Rules  Evaluating taxation for multiple states  What wages are subject to taxation?  Withholding compliance issues  State Unemplo...

Campus Active Shooter-Responding,Complying,Training

17 killed and over 14 injuries from the latest mass shooting at high school is a wakeup call for all schools and campus to embrace training for emergency preparedness. The deadly phase of an active shooter in your school/campus is over in the first four to eight minutes, statistically before the police can arrive and deploy. This means your employees are the first responders. An active shooter incident will unfold at lightning speed in terrifying conditions. The fatal flaw: your current response does not address the lethal first four to eight minutes for your employees to respond and your emergency team to take command.  FBI and NYPD report that Active Shooter incidents have quadrupled in 2013-16 versus the previous five-year’ average. Three people die and 3+ are injured in the average Active Shooter incident.  In this webinar expert speaker Bo Mitchell will help you learn how to create plans and procedures and how to train your emergency team and rank-and-file ...