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Life Sciences
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma [...]
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA [...]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. [...]
Overcoming Common Challenges of Customer Quality Complaint Handling
From food and beverage to electronics to CPG, there’s not a single type of manufacturer that’s immune to customer compla [...]
Supply Chain Traceability and The FDA Blueprint for Smarter Food Safety
From Listeria in ice cream to E. coli in lettuce, there’s one central question in any foodborne illness outbreak: where [...]
How to Establish Sustainable Validation for FDA & EU Compliance
Software validation is historically one of the most difficult compliance activities for life sciences companies. It’s al [...]
