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..
Have All Your Managers be Aware of all the Compliance Risks and How to Mitigate them! This Compliance Training will save your company over $300,000 in potential fines, violation and court settlements. Can you see how you can mitigate risk when you train your Managers? Can you afford to lose $300,000 plus?How many Managers and Supervisors are training to be managers or leaders? Many Managers are promoted bec..
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..
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..