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Form I-9 Coronavirus (COVID-19) Alert: USCIS Announces Temporary Modifications to Employment Eligibility Verification Process and E-Verify Program!
In response to the new challenges presented by the coronavirus pandemic, the Department of Homeland Security (DHS) has announced temporary flexibility in the requirements for completing Form I-9, Employment Eligibility Verification, while employers are operating remotely. DHS also has extended the time in which employers may respond to Notices of I-9 Inspection and the time in which to address certain E-Ver..
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..
Functional System Requirements for Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Defining the functional re..
Functional System Requirements Planning for Computer Systems Regulated by FDA
This course is intended to provide specific guidelines for coaching attendees on the best practices for developing requirements for computer systems regulated by FDA. There are several key types of requirements that will be covered, including user, functional, performance, system, environmental and other categories.The attendee will learn about the requirements for planning, executing and documenting the re..
Fundamentals in Discharge Planning for RN and Social Work Case Managers
This program will review the current rules and regulations from the Conditions of Participation for discharge planning. We will then discuss the most recent changes from the Medicare program and how they will impact the roles of the RN case manager and the social worker. We will review strategies for safely transitioning your patients across the continuum of care. In addition, we will review how to engage o..
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset
A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.Learning ObjectivesFundamental requirements of Good Manufacturi..
Fundamentals of S.W.O.T. for First Time Managers
S.W.O.T. is a key and fundamental building block in the strategic planning process for many organizations. It is a required skill in most capstone courses to graduate with a degree in Business Administration, Marketing or other types of business functions. And it is used as a common language in Most MBA curriculum. Yet it has lost some of its luster and resilience as a defining business and strategic model ..
GDPR, Are You Ready?
What is the regulation called GDPR? Is your business ready for the change? How do these new laws affect your business? What is sensitive data? These are some of the questions that this webinar called "GDPR, are you ready?" Can answer.This webinar is a comprehensive discussion on the General Data Protection Regulation from the EU. The General Data Protection Regulation (GDPR) which is designed to enable indi..
Generation of Controlled Documents and Related Training
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more..
Getting to Gross
In this webinar, attendees will learn the difference between regular pay, gross pay, and taxable gross, all of which may be different numbers! This can prepare the payroll team to respond to questions from employees who don’t understand their paychecks. We’ll discuss these questions: Do you know if any of your benefit plans are pretax? If you are in multiple states, are you aware of how each state regards S..
Global Cash Flow : How to Calculate and Use GCF to Determine a Borrower’s Ability to Repay
The webinar will explain how to, first, determine the cash flow from the borrowing entity available to repay debt, and, second, incorporate the available cash flow from guarantor individuals and entities. Analysis of these various cash flows means quantifying existing and proposed debt and adjusting cash flows for living expenses and other costs. Speaker will use case studies, slides, problem-solving skills..
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing..
GMP’s Applied to Medical Cannabis: All You Need to Know
When we discuss growing, producing, and manufacturing medical cannabis, we must think of it as a medicine. Medicine by definition is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and qual..
Going From Excel Pivot Tables To KPI Dashboards
IBM states that the data professional jobs projected to grow fastest are Business Intelligence (BI) Data Analytics and Data Visualization/Dashboards. The Demand for Data Analytics and BI Dashboard work alone is projected to grow by 44% over the next two years! 1. Source: IBM: The Quant Crunch, how the demand for data science skills is disrupting the job market.If you have a career that involves creating rep..
Good and Bad Practices in Risk Analysis
Selecting the most appropriate risk treatment option involves balancing the costs and efforts of implementation against the benefits derived, with regard to legal, regulatory, and other requirements such as social responsibility and the protection of the natural environment. A number of treatment options can be considered and applied either individually or in combination. Risk treatment itself can introduce..