BLOG
Life Sciences
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 [...]
Risk Management Programs: What The Latest Wave of HIPAA Fines Mean
The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don't bet on it.
Weak CAPA Programs Hit Globally by FDA Warnings
Life sciences companies around the world better make sure their Corrective and Preventive Action (CAPA) plans are in good shape before an inspector comes calling.
