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This Week in Quality Digest Live
FDA Compliance Features
Richard Harpster
Design failure mode and effects analysis (DFMEA) and a look at better masks to prevent spread of Covid-19
Natalie Weber
How an audit is conducted has changed significantly. Why audits are conducted is exactly the same.
Jon Speer
A survival guide for medical-device quality managers
Grant Ramaley
Edition 3.2 compliance costs will likely create major challenges for manufacturers of medical electrical devices
Jon Speer
When failure is not an option

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FDA Compliance News
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy

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Special Report: Hazardous Substance Process Management—Part 2

Video Information

This is Part 2 of our series on hazardous substance process management.

 

In this episode we cover:

* Taiwan's electronics industry as the birth of Hazardous Substance Process Management

* Why Taiwan saw QC 080000 as a means to ease ROHS compliance

* The passing of ROHS-type legislation in California 

* How audits from registrars such as Intertek strengthen ROHS compliance

 

For more information and a free white paper on QC 080000 click here.

 

Don't miss the other episodes of this series:

 

Special Report: Hazardous Substance Process Management—Intro

Special Report: Hazardous Substance Process Management—Part 1

Special Report: Hazardous Substance Process Management—Part 2

 
 

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