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FDA Compliance Features
Could Pressure for Covid-19 Drugs Lead the FDA to Lower Its Standards?
Leigh Turner
Mounting evidence indicates the agency’s Coronavirus Treatment Acceleration Program may be inadequate
Fake PPE on the Rise: Don’t Get Fooled
Dirk Dusharme @ Quality Digest
Government agencies and consumers fall prey to knockoffs and unapproved vendors
This Time, It’s Not All China’s Fault
Stanley Chao
Suddenly, everybody and their brother thinks they know how to do business in China
The Problem With Fake N95 Masks
Quality Digest
PPE counterfeits endanger lives. Testing ensures real PPE does its job.
Possible Cure for Outbreak of Fake Certificates From Covid-19 Pandemic
Grant Ramaley
The IAF certification database could help confirm the quality of medical purchases by governments

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FDA Compliance News
Study Finds Quality Shifting From Operational Compliance to Strategic Business Driver
Good quality is adding an average of 11 percent to organizations’ revenue growth
Greenlight Guru Updates Risk Management to Align With ISO 14971:2019
Further enhances change management capabilities
Greenlight Guru Announces New Integration With Jira Software
Creates adaptive system for managing product development and post-market quality for devices with software elements
FDA Opens Voluntary Qualified Importer Program (VQIP) Application Portal
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
IVT’s Validation Week 2018
An invite from Alcon Laboratories
FDA Plans to Use ISO 13485 for Medical Devices Regulation
Intended to harmonize domestic and international requirements
Pharma Companies Expect Role of Quality Management Teams to Evolve in 2018
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Hands-On Workshops at IVT’s Quality Risk Management and Change Control 2018
Feb. 27–March 1, 2018, in San Diego
ETQ Announces Acquisition by TCV
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy

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Profiles in Quality: Grace Duffy on H1N1 Vaccination Program

Video Information

An interview with Grace Duffy, Public health expert for the American Society for Quality and coauthor of The Public Health Quality Improvement Handbook, along with Ron Bialek and John Moran.

 

Duffy discusses how quality improvement tools were used as part of the H1N1 vaccination program.

 

This interview was recorded at the 2009 Quality Expo, prior to passage of the latest federal health care legislation.

 
 

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