Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
: Edwin Waldbusser
Recorded Webinar

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
Introduction to Statistical Process Control
Introduction to Statistical Process Control
: William Levinson
Recorded Webinar

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
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
: Susan Strauss
Recorded Webinar

Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua.....

$200.00
Acceptance Sampling for Variables: ANSI/ASQ Z1.9
Acceptance Sampling for Variables: ANSI/ASQ Z1.9
: William Levinson
Recorded Webinar

This webinar will show how to use ANSI/ASQ Z1.9 (formerly MIL-STD 414) to define sampling plans for products with continuous-scale (variables) data, and use the accompanying switching rules to move between normal, reduced, and tightened inspection as required by the publication.ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a widely accepted standard for sampling by variables (continuous scale measurements). The s.....

$200.00
The Dynamic Control Plan
The Dynamic Control Plan
: William Levinson
Recorded Webinar

Failure mode effects analysis (FMEA) and the control plan are both parts of advanced quality planning (AQP). FMEA, in fact, defines the control points or critical nodes of the control plan; process activities that must be controlled to ensure conformance of the critical to quality (CTQ) product characteristics. The dynamic control plan is a natural combination of the process FMEA and control plan into a sin.....

$200.00
Business Corruption and FCPA Issues in China
Business Corruption and FCPA Issues in China
: Craig Taggart
: 21 December 2018
: 01 : 00 PM EST
: 90 Minutes

As China continues its ascent as a global economic power, issues involving China under the Foreign Corrupt Practices Act, (FCPA) have emerged as a major business problem for multinational companies (MNCs). In a recent Wisconsin Law Review article, "China under the Foreign Corrupt Practices Act," the speaker discussed several major issues under the FCPA that concern MNCs doing business in China. This webinar.....

$149.00
Drafting Document Retention Policies
Drafting Document Retention Policies
: Mark Henriques
: 07 January 2019
: 01 : 00 PM EST
: 90 MINUTES

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.....

$149.00
Soup to Nuts: The Fraud Risk Assessment Process
Soup to Nuts: The Fraud Risk Assessment Process
: Danny M. Goldberg
: 14 January 2019
: 12 : 00 PM EST
: 120 Minutes

The FRA is an important aspect to any anti-fraud program. It is the foundation to build upon for fraud prevention in an organization. This two-hour course will take attendees through the basics of building a fraud risk assessment, how to build a library of potential risks, appropriately weighting risks and utilizing the FRA to build a successful anti-fraud program in any organization.Introduction and Backgr.....

$200.00
Improve Your IRS Compliance: Use Best Practices for TIN Solicitation
Improve Your IRS Compliance: Use Best Practices for TIN Solicitation
: Craig Taggart
: 16 January 2019
: 01 : 00 PM EST
: 90 Minutes

This IRS regulatory compliance training will explain the Best TIN Solicitation Best Practices. While TIN solicitation might sound too lascivious for the legitimate business world, it is critical that every organization take this task seriously. For if they don't, a very uncomfortable and costly audit with the IRS is likely to ensue.Areas CoveredIdentify all required TIN information you need to collectDesign.....

$149.00
How to Set up an Internal Audit Program
How to Set up an Internal Audit Program
: Joseph Azary
: 17 January 2019
: 01 : 00 PM EST
: 60 Minutes

An overview of how to set up an internal audit program to address quality management system standards, government regulations, risk management as well as usage for continuous improvement.This is especially useful for small to medium sized medical device companies and start-up companies to ensure that all of the applicable regulatory requirements are incorporated into the system to ensure compliance to all n.....

$149.00
Quality by Design (QbD) for Analytical Methods
Quality by Design (QbD) for Analytical Methods
: John C Fetzer
: 22 January 2019
: 01 : 00 PM EST
: 60 Minutes

This 60-minute presentation will highlight the use of statistical tools to monitor operations for a proactive operation.There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is.....

$179.00
Audit Report Writing
Audit Report Writing
: Danny M. Goldberg
: 27 SEPTEMBER 2018
: 04 : 00 PM EST
: 120 MINUTES

Audit Reports can significantly lose their effect if not written professionally. Writing an audit report is a fine art and, once perfected, can take on more importance than the audit itself. In this course, attendees will learn, in-depth, about each component of an audit report and how to set the correct tense and clarity to gain the most effectiveness.Audit Report Structure a. Executive Summary b.....

$300.00
Audit2020: Evolving the Internal Audit Process
Audit2020: Evolving the Internal Audit Process
: Danny M. Goldberg
: 07 December 2018
: 02 : 00 PM EST
: 120 Minutes

The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 is a course that takes an in-depth look at the accepted practices inherent in internal audit and critically analyses each piece, identifying ways to en.....

$200.00
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