FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters ..
Companies are overflowing with information. Data is generated at a remarkable rate. What can be kept? What can be destroyed? This timely information helps the persons responsible for drafting document retention policies define the key objectives of the policy and satisfy the necessary legal requirements. Learn the proper elements of legal hold and the consequences for failing to properly implement such hold..
This 60-minute webinar is intended for anyone who, like the trainer, has a technical background. We will look at the benefits of effective communication, the underlying principles, and how they might be successfully applied in a range of typical situations. The overall aim is to help scientists and engineers identify the aspects of communication that they currently do well, and aspects that they can usefull..
Emotionally intelligent managers, supervisors and professional staff are your greatest assets. They solve problems, resolve conflict and build teamwork. Researchers and business experts agree that people with high emotional intelligence (EQ) are consistently the top performers in their organizations. They’re more resilient and flexible when things get tough, and are held in the highest regard by their bosse..
In this beneficial presentation, Excel expert David H. Ringstrom, CPA, introduces you to Excel dashboards. Dashboards are quite popular because they empower users to quickly assimilate large amounts of data by way of charts and summary tables. David demonstrates how to: use Excel’s Pivot Table feature to create charts that display data trends, filter data faster using the Slicer feature in Excel 2010 and la..
Extracting data from text files or from database management systems, such as Microsoft Access or Microsoft SQL Server, can be intimidating to Excel users. In this outstanding presentation, Excel expert David Ringstrom, CPA, walks you through the process of getting the data you need from databases or from text files into Excel. Once your data is in Excel, you can work with it in a variety of ways, such as us..
In this presentation, Excel expert David Ringstrom, CPA, shares a variety of ways you can automate your work in Excel by way of the Custom Views feature—one of Excel’s most overlooked features. Step-by-step, David demonstrates how Custom Views allows you to hide and unhide multiple worksheets at once, set a print range for multiple areas of a worksheet, make a single set of data serve multiple purposes, gai..
In this insightful webcast, Excel expert David Ringstrom, CPA, focuses on alternatives to the VLOOKUP function. While many Excel users rely on VLOOKUP for basic lookup functionality, it’s often because they’re unaware of other functions that can enable them to work more efficiently in Excel. David sheds light on what can go awry with VLOOKUP; explains how to future-proof VLOOKUP; and discusses alternative f..
Identifying for employers compliance issues which they need to address in order to be in the best possible position to defend an I-9 audit by Immigration & Customs Enforcement (“ICE”). Form I-9 compliance goes beyond just filling out the form. It requires that every business have Form I-9 Policies and Procedures in place that cover topics such as properly making corrections on a Form I-9, storage of For..
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..
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..
The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..
Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations.Most disciplinary policies are progressive. A progressive policy applies increasingly more severe sanctions to additional incidents of bad behavior. It is very im..
The United States Citizenship and Immigration Services (“USCIS”) released a newly revised Employment Verification Form, Form I-9 on November 14, 2016. Employers are required to use the Form I-9 to verify the identity and employment authorization eligibility of their employees. The new Form I-9 will become mandatory on January 22, 2017.The new Form I-9 contains many changes – it is now 3 pages long with an a..
The purposes of an organization’s human resources are to add value, make the organization more competitive, help the organization achieve its business objectives, and manage key risks. The purposes of HR metrics are to help communicate the value added, demonstrate the contribution of human capital, and measure employment-related risks. In this environment, the key issue in becoming a strategic partner is fo..