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...
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Showing posts with the label OSHA compliance webinar
Handling Multi-State Payroll Taxation
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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
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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 ...
New EEO-1 Reporting and Compliance 2018
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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...
USDA GMO Labeling Update
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GMO labeling is a controversial topic and there have been many different approaches to GMO labeling, with individual states attempting to have their own labeling laws. Finally, a federal law was passed last year that preempts state laws, but there are still some unresolved issues that will be addressed in this audio conference. This session by expert speaker Norma Skolnik will discuss how to effectively label products with GMO ingredients and still comply with regulatory requirements. It will also cover what to expect when the July 2018 USDA regulations will be issued. Norma will provide you with references to all relevant FDA regulations , guidance documents, and FDA websites for GMO labeling. You will also gain regulatory insights and will learn about the FDA contacts and know-how tips. Session Highlights: Status of GMO’s in the USA FDA Position on GMO’s/GE foods FDA Biotechnology Policy & Consultation Program World...