All FDA Regulated Industry

$200.00
Human Error Reduction Techniques For Floor Supervisors

 Recorded Webinar
 90 Minutes
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Human Error Reduction Techniques For Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..

$200.00
Human Error Solutions: How we Reduced 60% of Human Errors in Less than a Year, a Case Study

 Recorded Webinar
 90 Minutes
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Human Error Solutions: How we Reduced 60% of Human Errors in Less than a Year, a Case Study

Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..

$200.00
Human Factors and Ergonomics in New Product Development: Methods and Technique

 Recorded Webinar
 60 Minutes
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Human Factors and Ergonomics in New Product Development: Methods and Technique

Human factors engineering is extremely integral to user/market adoption. Getting a product to market is difficult whether you are a struggling startup or an established original equipment manufacturer (OEM). Understanding some of the tools available on the front end of product development can help you avoid downstream problems before they become time and money wasters. Human factors engineering is one such ..

$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
Human Factors/ Usability following ISO 62366 and new FDA Guidance

 Recorded Webinar
 60 Minutes
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Human Factors/ Usability following ISO 62366 and new FDA Guidance

Human Factors/Usability is an analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating results with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to t..

$200.00
Human Factors/Usability Studies following ISO62366 and the new FDA Guidance

 Recorded Webinar
 60 Minutes
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Human Factors/Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the n..

$200.00
IEC 62304 for Medical Device Software

 Recorded Webinar
 60 Minutes
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IEC 62304 for Medical Device Software

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..

$200.00
Implementing a Robust Data Integrity Program

 Recorded Webinar
 90 Minutes
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Implementing a Robust Data Integrity Program

Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification w..

$200.00
Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

 Recorded Webinar
 90 Minutes
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Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to ..

$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
Internal Audit for Medical Device Companies

 Recorded Webinar
 90 Minutes
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Internal Audit for Medical Device Companies

Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your i..

$200.00
International Codes and Medical Device Reporting

 Recorded Webinar
 60 Minutes
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International Codes and Medical Device Reporting

The US FDA receives over 100,000 reports a year of medical device adverse events including deaths, serious injuries, and malfunctions. Because of this high number of reports, the FDA sought ways to sort the data using hierarchical coding systems that included a device problems code; a manufacturer’s evaluation for the event: methods, result, and conclusion; and also information on the patient and the device..

$200.00
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?

 Recorded Webinar
 90 Minutes
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Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?

The EU MDR 745/2017 is a complete game-changer to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show, how to conduct a gap analysis, an action plan and how to be on track until May 2020. Learn, what to do into the quality management department and what to do in the regulatory affairs..

$200.00
Issues in Calibrations and Accuracy in Method Validation

 Recorded Webinar
 60 Minutes
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Issues in Calibrations and Accuracy in Method Validation

Accuracy, the ability of a methodology to give results within acceptable limits when compared to known values, is a fundamental and key requirement. Calibration is the most common approach to obtain accuracy.Accuracy requires a comparison to a validated material. The level of confidence depends on traceability, a chain connecting the samples of interest all the way to the specific metric standards. This..

$200.00
Laboratory Investigation of Out-of-Specification (OOS) Results

 Recorded Webinar
 60 Minutes
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Laboratory Investigation of Out-of-Specification (OOS) Results

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that ar..

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