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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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Today's show

it's arguable that healthcare has made little progress in error proofing and quality improvement over the last 20 years. I interviewed Paul O'Neill this week, former Treasury Secretary, former CEO of Alcoa, and former chair of the Pittsburgh Regional Health Initiative, and he bemoaned how little improvement there's been:

“The tragedy is, as straightforward as these ideas are, leadership in health and medical care institutions around the country have not grabbed these ideas and implemented them, which is, frankly, unbelievable when it’s so clear that the benefits are not only to significantly better outcomes for health and medical care, but significant cost reductions at the same time.”


O'Neill points to a lack of leadership as a root cause of this problem. Healthcare quality is largely not a technical issue, it's a people issue.