All FDA Regulated Industry

$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..

$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
Managing an FDA Foreign Inspection

 Recorded Webinar
 60 Minutes
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Managing an FDA Foreign Inspection

Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..

$200.00
Managing The Audit Function In A Global Company

 Recorded Webinar
 90 Minutes
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Managing The Audit Function In A Global Company

Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..

$200.00
Managing the Transportation of Perishable Food Products

 Recorded Webinar
 90 Minutes
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Managing the Transportation of Perishable Food Products

This session is designed for any food industry supply chain players who rely on transportation delivery controls. Air Cargo, trucking, rail, freight forwarders, shippers and others in the food supply chain are key players in the transportation of temperature and humidity-controlled food goods and can benefit financially from offering sanitary and value-added sensor technology to their service packages. The ..

$200.00
Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries

 Recorded Webinar
 90 Minutes
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Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries

Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalize..

$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..

$200.00
Medical Device - Engineering change control

 Recorded Webinar
 60 Minutes
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Medical Device - Engineering change control

Companies need to be able to adapt quickly in today’s constantly changing environment, and often that means making changes to their products. Engineers make modifications during development and production with the intent of adding functionality, improving manufacturing performance or addressing the availability of a particular part. To make sure proposed changes are appropriately reviewed, a solid process i..

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