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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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Profiles in Quality: Jim Harrington--Episode 2

Video Information

This is the second episode of our interview with noted quality management consultant Jim Harrington at his home in Los Gatos, CA. Here, Jim talks about quality in China.
 
 

Discuss1

Comments

Please stick with Quality, not Morality

Quality Digest and Thomas Pyzdek are not recognized or qualified as commenters on any moral issues. While I value both of them, I value them for their knowledge of Quality. Please remain focused on Quality.

It's not ok to shoot the minister of trade

Harrington's reaction to the Chinese shooting their Minister of Trade because of the lead in paint issue is that they are showing that they think that quality is important. Interviewer Dirk Dusharme's response is to chuckle. I think that killing someone because of a mistake is wrong. Let's not condone brutality. Let's not gloss over the moral issues.

Thomas Pyzdek
http://pyzdekinstitute.com