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. Testing is a very large co..
The United States Citizenship and Immigration Service has made several updates in regards to International work visa’s and how employers handle them. The form I-9 and E-verify to Employment eligibility. This webinar will give the participant all the recent updates that went into effect as of January of 2017 and how to implement those changes. The difference between employment concerns and payroll taxation w..
This webinar will introduce attendees to the foundations of statistical process control (SPC), including the effects of variation and accuracy on process quality. The definition of a Six Sigma process will be illustrated. Attendees will learn how to construct SPC charts that provide visual controls (easily understood signals) that tell production workers when the process requires adjustment to prevent the m..
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. There are legal, regulator..
Mail merge saves you significant time and effort, producing mass mailings and labels are much simplified, especially compared to the process of preparing individual letters or envelopes for many people.One standard letter can be created and sent to a huge range of recipients without having to manually add each name and address.MS Word "mail merge" creates personalized letters, emails, envelopes or mailing l..
How many times have managers/supervisors made decisions you as a business owner or company leadership wished they didn’t? The law is clear on what behaviors from managers are a risk of “Vicarious Liability”. This term has many implications for employers, employees, and managers. In fact, the Equal Employment Opportunity Commission (EEOC) has included managers who employees allege harassed them on any of the..
Managing Through Chaos: Tools, Tips and Techniques to Set Priorities and Make Effective Decisions Under Pressure
This highly interactive Webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical techniques for making structured decisions—even under pressure—to earn buy-in from bosses, coworkers and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case s..
Because the Anti-Kickback Statute is so broad it what it proscribes, healthcare organizations, conducting what would be normal marketing activities in other industries, have run afoul of the Statute on numerous occasions. The Statute and the regulations only tell part of the story. This program will review not only the Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and a..
Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenteral and medical devices. Sinc..
Ask managers what part of their job they find most taxing and tedious and the answer is sure to come in a loud and unanimous voice – Meetings. Too many, too often with too few results. Nothing seemed to get accomplished; the agenda was unclear; people were late…or didn’t even show up.Let’s face it. Meetings have a bad reputation; they are time wasters. The best you can hope for is to get through them. Right..
We have all heard of money laundering but did you ever wonder how it works? This course is designed to review the issue of money laundering. Examples of actual money laundering cases will be provided so participants can understand how these frauds are being committed and how they were uncovered. We will review various methodologies for detecting money laundering schemes and will discuss developing internal ..
This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..
Preparing a Financial Industry Compliance Manual and Code of Ethics and the Overall Annual Compliance Review
Building or Strengthening your firm’s Compliance Program? Attend our virtual seminar on the best practices for preparing the manual, code of ethics and conducting the required annual review. You will receive tools to help build or strengthening your compliance program. The Compliance program shall be designed to prevent, detect, and correct violations of the Advisers Act. The overall compliance program must..
How do we manage projects and customer relationships effectively? How do we understand the full scope of a customer “project”? How do we assemble the necessary resources to effectively manage a customer relationship and attendant projects? To whom do we delegate specific responsibilities and when? These are among a number of questions we discuss and about which we learn as we strive to effectively manage pr..
Proper Way to Terminate Employees with Performance Issues without Violating Title VII of the Civil Rights Act
Employers have always avoided the termination either because it is not easy to terminate someone or because it can be difficult to defend any allegations of wrongful termination. Cases of wrongful termination have emerged and increased since the late 2000 year. Research has identified the following factors in this increase: Employees more aware and knowledgeable of the workplace rightsEmplo..