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Showing posts with the label fda validation

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 ...

Form I-9 & E-Verify Update 2018

With the new form I-9 that was released on 11/14/2016 and then another one in July of 2017 there is a lot of confusion on what form to use and how the changes impact employers. We also have additional options of going electronic with the Form I-9 and options to validate employees electronically. This webinar will review all of your electronic options when it comes to the Form I-9 and how you company can best become more electronic. The Trump administration is cracking down on I-9 compliance are you ready for an audit.  In this webinar expert speaker Dayna J Reum, will provide a comprehensive overview of the employment eligibility statues and Form I-9 requirements. The webinar is essential for all company representatives who are involved in hiring and employment verification.  Session Highlights:  Understand the recent updates to the Form I-9 Understanding the new I-9 requirements for individuals working in the US on temporary work visas.  Review...

Tax Levies and Creditor Garnishments: What Payroll Must Know to Stay In Compliance for 2018

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Tax levies and creditor garnishments can be some of the most complex tasks required of any payroll department . If garnishments are not handled correctly, you may find yourself facing situations that become extremely costly both financially and emotionally. Courts, federal and state regulations, bureaucracies, lawyers and a multitude of other factors can complicate even the most basic procedures. Add in the emotional turmoil that often accompanies garnishment orders and even small errors can become major disasters.  In this webinar expert speaker Vicki M. Lambert will covers the complexity in the handling and compliance with tax levies and creditor garnishments by the payroll department. Discuss the Priorities between conflicting entities as well as federal and state compliance requirements are highlighted, and provide tips for reducing processing time and costs.  Session Highlights:  How to define the various types of tax levies and creditor garnishments...

Navigating the Family and Medical Leave Act

The Family and Medical Leave Act is probably one of the most difficult leave laws to navigate.  Understanding the various terms, calculating the leave to which an employee is entitled, determining what benefits you must provide to employees while on leave can be a legal landmine. This presentation will walk you through this legal landmine and provide with the nuts and bolts of what the Family and Medical Leave Act.  FMLA leave for family of military personnel buy these reference materials and receive the information needed to guide you through the maze of family and medical leave laws. You will learn how these old and new rules interplay with each other and ensure that your policies and practices are in compliance.  In this webinar expert speaker Susan Fahey Desmond, will sort out all the different types of medical leaves, clarify the associating factors between them, and give you a solid toolbox of best practices for understanding leaves, using them safely...
Overview of  FDA computer system  validation requirements, including 21 CFR Part 11 compliance FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place. The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry th...

Same Day ACH (Phase 3) : Moving Payments Faster

Same Day ACH is making payments faster, debits and credits are both in motion as of September 2017 – what is the impact on ACH Payments ?  Same Day ACH affects not only the billing game (from the Originator’s standpoint) and In-House Origination, but also on the Receiver’s side, with debits possibly affecting their accounts on the Same day they authorize the Entry. Companies don’t thoroughly understand the impact debits can have on sending and receiving ACH transactions. This session will identify and outline the different way that Same Day ACH is impacting the ACH Network as a whole.  For the Originator, with debits having Same Day settlement, this means faster collection! Authorization language for the Originator (this could even affect the ODFI who is doing in-house Origination to collect loan payments, for example), needs to be examined to ensure mention of a possible same day debit to the consumer account. With an uninformed Receiver, this could result in Entrie...

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...

Creative Ways to Use Linkedin as a Recruiting Tool

Linkedin can play an important role in social recruiting efforts enabling recruiters to reach out to potential candidates, match the skills and requirements with those in the extended network. Join us in this webinar to learn the best practices about incorporating this power-packed social networking website as an opportunistic gateway for qualified job seekers to apply with your company. Webinar Overview: During this webinar , you will learn how Linkedin can be used as a creative tool by hiring managers and employers to reach out to the best talent. Additionally, you will know how Linkedin can help you to get connected with the extended network of professionals in order to be precise on the skill required for any job. The conference will be highlighting the social aspect of the edge Linkedin has taken over, including fee-based recruitment advertising options. Key focus of the conference: How to improve hiring practices Key reasons to incorporate LinkedIn into rec ...

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...

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...

Section 504 and ADA : Student Disability Rights

The entirety of Section 504 is comprised of one sentence: "No otherwise qualified person with a disability in the United States...shall, solely by reason of...disability, be denied the benefits of, be excluded from participating in, or be subjected to discrimination under any program or activity receiving federal financial assistance." But what does this mean in the practical context of a post-secondary education, and what is expected of schools? Since the implementation of Section 504 and, later, the ADA, courts have been busy analyzing the language and deciding student disability rights issues. In this session, Erin D. Gilsbach, Esq. examines 10 prominent court cases that provide an expansive look at the legal expectations of student disability rights at postsecondary institutions. Through this process, she breaks down the key components of nondiscrimination and provides helpful tips on what it takes for postsecondary programs to pass muster under Section 504 and the AD...

Outlook On Steroids - MS Outlook 2013-2016 Tips

Work smarter and faster – boost your productivity, job satisfaction and professionalism. This presentation effectively demonstrates and teaches the key elements of Outlook beyond the basics, including power-user techniques, shortcuts, tips and tricks. It aims to provide the knowledge you need to understand and use the outstanding capabilities of this powerful application. Microsoft Outlook is widely seen as the market leader and powerhouse in managing email, appointments, tasks and contacts. The expert tuition and demonstrations provided in this webinar are essential for you to effectively grasp the full capability of this multifaceted personal information manager. Mastering Outlook is a fundamental, highly regarded and marketable skill set, vital in business, government and academic environments. Promote and attend this informative and value-packed 60 minute webinar with your team to boost efficiency and maximize your ‘return on investment’ in Microsoft Office. SES...

The Top Qualities Of Effective Recruiters

Recruiters have the tough job of sourcing high-quality candidates that meet business demands. But the main pet peeve of recruiters has always been their inability to onboard the candidate the hiring manager wanted. In today’s time its really important for hiring managers to know that there’s intense competition in the market for good candidates. We are seeing a candidate driven market for some skill sets and the best candidates always have choices. So if a recruiter is facing challenges closing a candidate they should let the hiring manager early on.    Recruiters usually care more about assessing a candidate’s qualifications rather than their seriousness and willingness to make a change. This ultimately leads to rejected offers. So it is better to ensure the candidate prefers the position offered by the company throughout the recruitment process.  1. Using the job description to show the candidate their impact on the company The job description is really a...