Risk management is an integral part of regulatory compliance for the pharmaceutical and medical device industries. While quality regulations for medical product manufacturers don’t always incorporate risk-based principles, creating compliance-implicated documents that the FDA reviews during an inspection should. ... Read more
The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management... Read more
FDA’s Upcoming Quality Metrics Submission Requirement: Data Driven Decision-Making or Letting the Students Issue Their Own Report Cards?
Although Corporate America has embraced the concept of metrics and dashboards for close to 20 years now, the US Food and Drug Administration (FDA) has only recently come to the conclusion that incorporating a review of company-provided product quality metrics... Read more