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For Corrective Action Plans, Where Are the Resources?
What sells at the FDA
Turning Point for Food Safety
A new certification scheme, FSSC 22000, is a major step forward in food manufacturing
Under-Promise, Over-Deliver
It costs more to get a new customer than to keep one
Food Safety Auditors’ Red Flag: No Documented Issues
Food plants are expected to have environmental issues, especially with pest management
Killing Time: How to Manage Interruptions
Thomas Edison had it right
Are You Prepared for Foreign Food-Supplier Verification Laws?
Food Safety Modernization Act puts burden of food safety on importers
Are You Prepared for Foreign Food-Supplier Verification Laws?
Food Safety Modernization Act puts burden of food safety on importers
Tips on Preparing for an FDA Inspection
Are you following current good manufacturing practices?
Congressional Committee to Reduce Waste, Eliminates Self
Audit of federal agency overlap runs up against entrenched confusion
QC, QA, Sensationalism, and “Seasoned Ground Beef”
Media wouldn’t know quality if it bit them in the burrito
Speed Up Your Medical Device Time to Market
Consider a presubmission technical file evaluation
FDA Inspections: When You Know You Have Problems
Choose your spot on the slippery slope
Digital Pen Speeds Data Management, Helps FDA Compliance
FactoryScribe converts paper to PDF
This Year in Quality, Part One
Outstanding people, new standards, and what we did with them
Comparing Pharmaceutical Continuous Monitoring Systems: Part 2
Wired, wireless, and stand-alone monitoring instruments
Comparing Pharmaceutical Continuous Monitoring Systems: Part 1
Looking at compliance, risk, and cost for stand-alone, wired, and wireless systems
Food Safety: Challenge or Opportunity?
How regulations are viewed prevents or enables them to promote business goals
When All Else Fails, Lower Your Standards
This seems to be the thinking for two pharmaceutical manufacturers
Savvy Compliance Strategy, Part IV
Closing the circle of compliance loop
21 CFR Part 11: Auditors Are at Your Door
FDA steps up inspections to detect fraud and data manipulation

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