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

FDA Compliance and Laboratory Computer System Validation

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidan ...

Live Webinar

Project Management for Non-Project Managers - Scheduling your Project

This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives. Participants will be walked through the scheduling process from start to finish in language that will clearly descr ...

Live Webinar

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Just as lean principles challenge traditional process concepts and "push ...

Live Webinar

FDA Regulation of Artificial Intelligence - Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...

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 ...