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Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive guidance agenda for 2017 from the Cente [...]
Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers meet expectations regarding an effectiv [...]
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities t [...]
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers new details and hones the scope preview [...]
Document Management Problems Threaten Pharmaceutical Manufacturers
Document management problems could soon impact the momentum in the number and speed of drug approvals for the pharmaceut [...]
Risk Management + Adverse Event Reporting: FDA Guidance
Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by new FDA gu [...]
