During this week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talks about lessons learned from the pandemic and 2021 goals.
For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
Leveraging the power of technology to create a more patient-centric approach and consolidate costs is expected to play a big role.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.
Understanding the GMP requirements of each component is critical to product and compliance success.
It’s time to consider CAPAs as opportunities rather than just other issues to tackle.
Top reasons for recalls include software, quality and parts issues.
A review of new, successful treatment options for the novel coronavirus.
No longer just “the big company advantage,” CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.