On-Demand Webinar
Pragmatic Approach to Pharmacovigilance/Drug Safety System Update Against the Latest New Requirements
In the last year/recent months, there have been a lot of changes in the pharmacovigilance requirements especially impacting the reporting to EudraVigilance, the Signal Detection Management (e.g. inclusion of EudraVigilance Data Analysis System as part of the Signal Detection Management, etc.) and the Risk Management activities. The course is aimed at providing some practical examples of the application of t..
Pre-Submission/Q-Sub for Medical Devices
This webinar will discuss all aspects of the US FDA Pre-Submission process. This webinar will review when a Pre-submission may be appropriate for a company or product. It will include a review of the guidance document. The types of Pre-submissions will also be reviewed including those for IDE applications, study risk determinations, Pre-Sub for a 510(k), Pre-Sub for a PMA and Pre-Sub for an IVD. The content..
Preparing a FDA 510(k) Submission
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial equivalence will be discussed. How to find an acceptable predicate device will be taught. FDA places special emphasis on-device software. we will cover the requirements for s..
Preparing a Financial Industry Compliance Manual and Code of Ethics and the Overall Annual Compliance Review
Building or Strengthening your firm’s Compliance Program? Attend our virtual seminar on the best practices for preparing the manual, code of ethics and conducting the required annual review. You will receive tools to help build or strengthening your compliance program. The Compliance program shall be designed to prevent, detect, and correct violations of the Advisers Act. The overall compliance program must..
Preparing for a (US and other) Customs Audit
US Customs law dates back to 1879 and was far less burdensome, legally, on the US importer until 1993. Under current law, the US Customs Modernization Act, the US Importer is now mainly responsible for adherence to all US Customs laws and regulations. While Customs calls it a “shared responsibility”, the burden is on the importer to “exercise reasonable care”. In this session, we’ll discuss the basics of a ..
Preparing for a BSA/OFAC Regulatory Examination
The BSA examination process is intended to assess the effectiveness of a financial institution’s BSA compliance program and the institution’s compliance with the regulatory requirements related to the BSA. A regulatory examination should cover a review of the risk management process, an analysis of the institution’s independent testing system, a detailed and thorough of the BSA compliance program, transacti..
Presentations that POP
Over the years people have been lulled into believing that doing a presentation simply means preparing a PowerPoint filled with bulleted slides and then reading through them for the audience. Everyone that has sat through one of these presentations knows that they are boring and hardly anyone can remember what was said during the presentation. That is NOT how it was meant to be.This course will give you bas..
Preserving America’s Affordable Housing
State, local, governments and Public Housing Authorities play a major role in contributing to the preservation of affordable housing. This webinar will present policies and best practices for state, local governments, and public housing authorities to preserve affordable housing, Also, this webinar will discuss the preservation of subsidized housing in rural and urban areas of the country.Participants will ..
Preventative Controls Approach for California’s Prop 65 for Food Industry
California’s Prop 65 enacted to inform its’ residents and workers the hazards associated chemicals and toxins that may cause harm has ballooned to over 900+ items, that industries must be aware of to operate within the state. The Food Industry has also been subject to Prop 65 legal battles on a host of products including French fries, chocolate, coffee, bakery products, candy and baby food that may now requ..
Preventing Harassment, Discrimination and Bullying in the Workplace: Today’s Climate Update for 2020 and Beyond
This course is designed for all employees in your organization. It is intended to help employees learn how to behave appropriately in today’s workplace.It has become clear that complaints are being made and honored about behaviors that in the past had seemed “too mild” to worry about. Only egregious sexual misconduct was brought to the attention of those in charge. Not so anymore. Today, even the mildest fo..
Preventing Internal Embezzlement and Employee Fraud
Each year, crime statistics show employee theft and embezzlement costing businesses and organizations billions, with new, more sensational stories appearing all too regularly in the Press. The pervasiveness of these crimes means no employer – whether for-profit, non-profit, governmental, or religious–can count itself as immune. Moreover, embezzlement and fraud also occur as insider crimes by partners, offic..
Preventing Sexual and Other Harassment/Discrimination Claims
The laws have changed – as of January 1, 2020, any employer with five (5) or more employees MUST offer this type of training. Employees include part-time, interns whether paid or not, and some contractors. It also includes people working in other locations, such as at home. Every day we are learning about more harassing, bullying, and abusive behavior on the part of men (mostly men – some women) who have be..
Principles for Hiring Great People
People are the primary resource and solution to all of your goals and dreams. It all starts with your ability to hire great people. The better you get at hire, the better everything turns out. You will learn critical elements, practices, and insights on how to hire the best people. Quality people will make your job easier, the organization better, and produce at a level of excellence most people only dream ..
Principles of a Shadow Payroll
US companies are becoming more global each day, and many employers are faced with many challenges when a U.S. employee is working abroad or when a foreign national is working in the U.S. Many countries have changed tax laws in the last several years that make companies look for different ways to maintain international assignments. Since tax equalizations are not enough anymore to mitigate the risks that emp..
Private Foundation Issues and Form 990-PF
Private foundations have many complex rules and potential traps for those managers and preparers unaware of the rules. This session provides an overview of Form 990-PF and basic information regarding excise taxes, potential penalties, and their implications for the completion of Form 990-PF. Learn the differences between non-operating (grant-making foundations) and operating foundations and planning suggest..