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Showing posts with the label FDA computer system

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 FSMA: Preventive Controls Food Safety Plan

"Food Safety Hazard Analysis and Risk-Based Preventive Controls Plan For Human & Animal Food " All food facilities registered with the United States Food and Drug Administration (FDA) must comply with the requirements under the Food Safety Modernization Act (FSMA) to develop and implement a Preventive Control Food Safety Plan that includes a Food Defense Plan. The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sanitation preventive controls and other items. The plan must be reviewed and approved by a preventive controls qualified individual (PCQI) and it must be validated.  In this webinar expert speaker  John Ryan  will discuss the company’s responsibility under FSMA is to assure that the plan is implemented, verified and validated. Speaker will cover plan development of the preventive control food safety plan and the development of the food defense plan.  S...

The Impact of New FSVP & Third Party Accreditation Rules on Your Food Business

The wait for final FSMA Rules is quickly ending and the implementation periods have begun. On November 10, 2015 the FDA published the final rules for the  Foreign Supplier Verification (FSVP) and Third Party Accreditation programs  and is now preparing guidance documents that extend the requirements previously published under the final rules for cGMP, Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food. Most businesses have less than one year for full implement compliance implementation.  Since the final FSVP and 3rd Party Accreditation rules rely heavily on new rules for HARPC, Environmental Monitoring, Validation and Validation of Preventive Controls. In this webinar expert speaker  John Ryan  will review earlier final rules and he summarize the final FSVP and 3rd Party Accreditation rules. It is critical to begin to understand how the FDA has interwoven the FSMA into more of a compact and focused set of rules than proposed rules ...

2018 New W-4 Form and Beyond

The Internal Revenue Service (IRS) has finally released an updated Withholding Calculator which reflects changes under the new tax law. Dec of 2017 The Tax cuts and jobs act was passed and it was one of the most significant tax changes in sometime. This webinar will prepare the payroll professional to understand the changes to the form W-4 for 2018 and beyond because of tax reform. Form W-4 is a critical form that all companies have to obtain from employees. And the IRS has specific laws and how they should be handled plus these laws change and it is important to keep current. With the new tax regulations going into effect just recently, the Internal Revenue Service (IRS) is still working on revising the W-4 form to reflect some changes.The IRS has now released an updated form W-4 for 2018 . join our webinar if you need to make changes to your withholding for 2018. In this webinar expert speaker Dayna Reum will Review potential recent updates, discuss concerns around proper...
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...