Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device ma [...]
6
03, 2017
20
02, 2017
Document Management + CGMP Compliance
Data integrity within your document management process is a critical component o [...]
14
02, 2017
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive [...]
23
01, 2017
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even mo [...]
16
01, 2017
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]
19
12, 2016
Document Management Problems Threaten Pharmaceutical Manufacturers
Document management problems could soon impact the momentum in the number and sp [...]
14
12, 2016
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.
8
11, 2016
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.
27
09, 2016
Cloud for quality and compliance management: A primer for life sciences companies
Here's what life sciences companies moving their quality and compliance management tools to the cloud can expect.
3
11, 2015
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, [...]
