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Showing posts with the label fda regulatory training

The Role of Student Handbooks and Codes of Conduct in Education Risk Management

"L EARN THE IMPORTANCE OF THE MATERIAL A SCHOOL UTILIZES IN IT STUDENT HANDBOOK” In the past,  handbooks aimed at students  in colleges and universities have contained basic information regarding topics such as academic standing, student discipline, housing rules and campus directories. However, evolving and advancing technology has forced both students and institutions to include much more information for the protections of both groups. This webinar will allow students, administrators and faculty to understand the changes in policies and what needs to be included in today’s (and tomorrow’s) student handbooks. In this webinar expert speaker  Kent Seaver , will discuss how student handbook can work in many different ways: informative piece, reference device, and legal shield. The overall safety of your campus is not only important, but how that is achieved and perceived can be the difference between success and failure. Knowing these roles is important to all stake ho...

FDA:- Adverse Event Reporting for Combination Products

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The FDA has published two key documents, these two guidance documents provide significant guidance to manufacturers of combination products. The guidance clarifies the regulations in terms of the provisions requiring applicants to submit additional types of adverse event and product problem reports to the FDA. The regulations also require mandatory sharing of adverse event information between companies manufacturing the individual constituent parts of a combination product.  Since these guidance documents have been recently published it is critical for manufacturers to fully understand their implications and individual applicant responsibilities under the post-marketing provisions in terms of how the regulations are clarified and interpreted.  In this webinar expert speaker  Charles H. Paul  will defines the post-marketing safety reporting for combination product and specifies and clarifies the FDAs policy for combination product post-marketing safety reportin...

Testing for Compliant Computer Systems for FDA

Effective and compliant computer system validation is critical to any pharmaceutical or F DA-regulated organization . Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.  In this webinar expert speaker  Carolyn Troiano , will discuss the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements . Speaker will also discuss the guidance for maintaining the system in a validated state and assessing the level of any testing tha0t might be required post-validation to ensure that compliance  Session Highlights:  Determine the category of your system, based on GAMP 5 from ISPE  Determine the ...

ACA Reporting Requirements 2018

Affordable care act was signed into law by president Obama on March 23, 2010 and since then employers have been asking themselves how to comply. The law changed how companies provided benefits, calculated payroll tax and most of all the new reporting requirements that must be followed. Now the employers have had 2 filing years to get used to the ACA law , the Trump administration is looking to repeal portions of the law.  This webinar with expert speaker Dayna Reum is designed to review Section 6055 and 6056 requirements and the reporting requirements, and to review what the potential changes might be and how that changes how we handle, benefits and payroll for our employees in the next months. Talks of repeal of the ACA or modifications have been all over the news as employers this webinar will discuss how to prepare in an unsure environment.  Session Highlights:  Up to date status on legislation and how it may impact employers  What reporting...

Child Support: Federal vs State Law Compliance

To bring a national standard to child support withholding laws , the Federal government has enacted laws that require states to adopt certain rules when setting their own standards for implementing child support requirements. These requirements include deadlines for withholding and remitting payments, filing procedures, and penalties and fines for violations. Payroll departments must know both the federal laws and the state laws and must determine which one applies to the child support withholding order. In addition to these laws and regulations, the federal rules now require that a standard Income Withholding Order (IWO) be used for all child support withholding garnishments.  In this webinar expert speaker Vicki Lambert will review this form and its requirements. And although the IWO can include all the information necessary to comply with the order, employers must familiarize themselves with both federal and state regulations to avoid penalties and liabilities. Withholding...

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...

FHA 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  Def...

DOL's Final Overtime Rule (FLSA) Updates for 2016

The Final Rule passed on May 18, 2016 and it focuses primarily on updating the salary and compensation levels needed for Executive, Administrative and Professional workers to be exempt. Specifically, the Final Rule: Sets the standard salary level at the 40th percentile of earnings of full-time salaried workers in the lowest-wage Census Region, currently the South ($913 per week; $47,476 annually for a full-year worker) Sets the total annual compensation requirement for highly compensated employees (HCE) subject to a minimal duties test to the annual equivalent of the 90th percentile of full-time salaried workers nationally ($134,004) Establishes a mechanism for automatically updating the salary and compensation levels every three years to maintain the levels at the above percentiles and to ensure that they continue to provide useful and effective tests for exemption. Additionally, the Final Rule amends the salary basis test to allow employers to use non-discretionary ...

OSHA Workplace Accident Investigations for HR Professionals

Accidents can cause an organization to lose valued resources including productivity and resources. In order to pay for costs related to accidents, the employer will have to divert profits to cover direct and indirect costs of the accident. The study of accident causation and investigation is imperative to protecting an employer from human loss and organizational losses. Many workplace accidents are also related to OSHA violations. Therefore, the accident can cost even more by adding the price of an OSHA citation.  OSHA has released the new Injury Tracking Application (ITA) for electronic injury and illness recordkeeping reporting. However, not everyone is required to submit their records due to specific guidelines for this new ruling.  In this webinar expert speaker Sheldon Primus will help you learn how to investigate the accident site, analyze the facts, recognize the contributing factors, determine the root cause, document the investigation, take corrective actio...

EIV: Are you Doing it Right ?

The Enterprise Income Verification (EIV) system is a web-based computer system that contains employment and income information of individuals who participate in HUD rental assistance programs. All Public Housing Agencies (PHAs) are required to use HUD’s EIV system.  The purpose of the Enterprise Income Verification (EIV) function within the Real Estate Assessment (REAC) Center is to ensure that limited Federal resources are available to serve as many eligible families as possible by reducing the high incidence of program errors and to improve the integrity and accuracy of information contained in the PIC and EIV systems. Additionally, EIV collects supplemental employment and benefit information through data sharing agreements with the Social Security Administration (SSA) and the Department of Health and Human Services (HHS). These agreements, in combination with HUD’s PIC system and EIV reports, provide an analysis of income and benefit information that the EIV team monitors...

New EEO-1 Reporting and Compliance 2018

ne of the most important forms is the annual EEO-1 where you have to identify the race and gender of your employees by various employment categories. The EEOC uses  EEO-1 data to support  civil rights enforcement and to analyze employment patterns, such as the representation of female and minority workers within companies. The OFCCP uses the data to determine which company establishments to select for compliance reviews. The deadline for filing your EEO-1 report is right around the corner! It is vitally important that you prepare this form correctly as the Equal Employment Opportunity Commission and the Office of Federal Contract Compliance Programs uses your information to determine whether your company should be audited. Inaccurate information could also suggest willfulness in not being honest which can lead to penalties or criminal charges. While the document may seem “just a piece of paper,” classifying your employees correctly can be a difficult task. Gathering the in...

Let’s Get Back to Basics: Withholding, Depositing and Reporting Federal Taxes

Federal income taxes are such a common occurrence in present times it is easy to forget their relatively recent origin. It is also easy to forget that the withholding of these taxes fall under IRS regulations that are strict and non-yielding in many cases. Simply put, the employer either collects the amount due from the employee or pays their own portion and sends it directly to the IRS. But though it sounds simple and basic it is critical for the employer to withholding the taxes correctly based on several factors including:  The type of payroll frequency used by the employer  The information supplied on the employee’s Form W-4  The taxable wage base and rate in effect for OASDI or social security taxes  The rate in effect for Medicare tax  If the employee is subject to the Additional Medicare Tax  Status of the employees such as nonresident alien or expatriate  The wage base and rate in effect for federal unemployment i...

Construction Risk Management with Current Issues & Real Life Examples

Construction projects entail considerable risk. Profit margins are relatively low when compared to the investment made, and often estimates of cost can only be based on best guesses. Therefore, it is critical to manage and minimize the exposure to risk. Fortunately, there are several opportunities in the life of a project that allow for significant risk management . These opportunities start with the decision of whether or not to bid, and following through to the bidding, subcontracting, and management phases. In this webinar Expert Speaker Fritz Marth will explore the risk management strategies that can be employed at the various times, and in the various aspects, of a construction project. Using real-life examples, Speaker will also explore the successful implementation of these methods, as well as instances where a failure to manage risk resulted in unsuccessful outcomes. Session Highlights:  Assessing whether or not to bid a project Developing an adequate bid Proper...