$200.00
How Successfully Apply for a Breakthrough Therapy Designation

 Recorded Webinar
 60 Minutes
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How Successfully Apply for a Breakthrough Therapy Designation

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..

$200.00
How To Deal With the Disruptive Practitioner

 Recorded Webinar
 60 Minutes
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How To Deal With the Disruptive Practitioner

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..

$200.00
How To Properly Complete the NEW Form I-9

 Recorded Webinar
 60 Minutes
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How To Properly Complete the NEW Form I-9

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..

$200.00
HR Metrics: Measuring and Communicating the Strategic Value of Human Resources

 Recorded Webinar
 60 Minutes
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HR Metrics: Measuring and Communicating the Strategic Value of Human Resources

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..

$300.00
HR Workplace Compliance Overview for Managers & Supervisors

 Recorded Webinar
 180 Minutes
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HR Workplace Compliance Overview for Managers & Supervisors

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..

$200.00
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

 Recorded Webinar
 60 Minutes
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Human Factors Validation Testing Following ISO 62366 and new FDA Guidance

Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required the number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test...

$200.00
In Depth Testing of Computer Systems Regulated by FDA

 Recorded Webinar
 60 Minutes
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In Depth Testing of 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. Testing is a very large co..

$200.00
International Visa's and 2017 Updates and How they Affect Employers

 Recorded Webinar
 90 Minutes
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International Visa's and 2017 Updates and How they Affect Employers

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..

$200.00
Introduction to Statistical Process Control

 Recorded Webinar
 60 Minutes
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Introduction to Statistical Process Control

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..

$200.00
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA

 Recorded Webinar
 60 Minutes
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Legal, Regulatory and Policy Issues Related to Validation of 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. There are legal, regulator..

$200.00
Management, Legal and Contractual Perspectives of Managing Remote/Virtual and Telecommuter Workers

 Recorded Webinar
 90 Minutes
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Management, Legal and Contractual Perspectives of Managing Remote/Virtual and Telecommuter Workers

More and more organizations are “going virtual,” whether it is an employee who telecommutes, a team of workers in another country, or simply an employee who extends her or his workday by checking e-mail or downloading a document from Dropbox that connects to their phone, iPad, or home computer. Approximately 80% of U. S. workers continue to do business remotely after normal work hours. More and more organiz..

$200.00
Managers Should Consider “Vicarious Liability”, When Conducting Disciplinary Actions!

 Recorded Webinar
 90 Minutes
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Managers Should Consider “Vicarious Liability”, When Conducting Disciplinary Actions!

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..

$200.00
Managing Through Chaos: Tools, Tips and Techniques to Set Priorities and Make Effective Decisions Under Pressure

 Recorded Webinar
 90 Minutes
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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..

$200.00
Marketing to Medicare or Medicaid Beneficiaries - What you Can and Cannot DO

 Recorded Webinar
 60 Minutes
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Marketing to Medicare or Medicaid Beneficiaries - What you Can and Cannot DO

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..

$200.00
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

 Recorded Webinar
 60 Minutes
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Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

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..

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