Search Trainings

251 results of "Life Sciences x" and "Medical Devices x"
Live Webinar

Risk-based Design Control - The New Paradigm for Medical Device Design

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.  Design control is not only a requirement of t ...

Live Webinar

The FDA and Cosmetic Oversight- What does that look like?

"The FDA and Cosmetic Oversight - What does that look like?" is a training session aimed at providing participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating cosmetics. The training covers various aspects, includi ...

Live Webinar

Risk Management for Medical Devices per ISO 14971 2019

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consi ...

Live Webinar

Project Management for Non-Project Managers - Determining the work that needs to be done

This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages. Decomposing a task is not a trivial or an intuitive process.  It is something that must be explained an ...

Live Webinar

European Union Device Regulation (EU MDR)

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes". In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The ...

Live Webinar

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Qu ...

Live Webinar

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

Live Webinar

FDA 483 or Warning Letter? Now what?

The training on "FDA 483 or Warning Letter - Now What?" is a comprehensive program designed to equip professionals in FDA-regulated industries with the knowledge and skills needed to effectively navigate and respond to regulatory challenges. When faced with an ...

Live Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For example, while a defect-free process is desirable, a test ...

Live Webinar

Medical Device 510(K) Submissions

There are 3 types of 510(k) submissions that can be submitted – Traditional, Special, and Abbreviated. The 510(k) process is considerably more rigorous than it once was, because of the following: Several international standards recognized by the FDA have b ...