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What Should Really Trigger a CAPA?
CAPA-worthy or CAPA-happy?
Is the FDA Creating a HACCP Program for Produce?
New FDA rule proposes that farms conduct water assessments rather than previously required tests
Boosting Vaccine Production Needs the Right Degree of Flexibility
The unequal access to Covid-19 vaccines stems from production shortfalls
Reporting All Biosafety Errors Could Improve Labs Worldwide
There’s no central reporting system in the U.S. or internationally
What Is Blockchain 2.0, and Why Should Food Manufacturers Care?
Benefits and challenges of becoming an early adopter of the technology
Operational Readiness: The Precursor to Operational Excellence
Management teams must shift their focus from a process qualification milestone to an operational readiness milestone
Inspection and Compliance in One Reliable Package
The Olympus CIX100 inspection system enables 21 CFR Part 11 compliance
The FDA’s Weak Drug Manufacturing Oversight Is a Potentially Deadly Problem
Current manufacturing oversight in the United States and overseas is hampered by staff shortages and limited funding
How Food Processors Can Improve FDA Compliance and Productivity at the Same Time
Tubular cable conveyors can be flushed with water, rinsed, and sanitized without disassembly
How to Build Medical-Device Usability Testing and Validation Into Your Quality System
A proactive approach to product development
How Does Analytical Testing Improve Food Quality?
Technology and processes improve food quality and purchaser trust
FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic
A flexible approach for ensuring access to safe, high-quality food and medical products
Food Safety Management System Certification Schemes, Highly Effective, But… What a Bunch of Them!
What is needed is one scheme accepted by all
Medical Laboratory Testing: How Can We Trust the Results?
One way is through a system of conformity assessment to ISO standards
Better Data for Use and Safety Profile of Cannabidiol (CBD) Products
The FDA examines new ways of building the science to inform public health decisions
How Risk-Based Thinking Could Prevent Thousands of Covid-19 Deaths
Design failure mode and effects analysis (DFMEA) and a look at better masks to prevent spread of Covid-19
Fine-Tuning Remote Audits During Covid-19
How an audit is conducted has changed significantly. Why audits are conducted is exactly the same.
Four Essential Processes in Medical Device Risk Management
When failure is not an option
Evidence-Based Ergonomic Risk Analysis for Environmental Health and Safety
Software tool aids cost, liability analysis for ergonomics issues
Investing in Advanced Manufacturing to Support Public Health Preparedness
Adaptation in the face of adversity

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