MHRA’s “Right Environment”
Former FDA Investigator Peter Baker gives insight to MHRA’s GXP guide for data integrity.
Peter Baker
July 18, 2019
Former FDA Investigator Peter Baker gives insight to MHRA’s GXP guide for data integrity.
There were six warning letter postings during this week, including one regarding Akorn’s site in Somerset, NJ that the company announced a few weeks ago.
GMP expert Barbara W. Unger provides her assessment of CDER’s State of Pharmaceutical Quality Report.
A surprisingly busy week for enforcement considering the federal holiday. Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy.
Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.
When it comes to data integrity, audit recommendations, and corrective actions, the correct data analysis is essential for making informed, impactful decisions.
Can mindfulness influence data integrity? Discover the insights Julie Maurhoff, a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical, gained after researching the topic.
Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.
In May of 2019, we added 262 FDA 483s to our database of 27,500+ FDA inspection documents.
CONTACT US: 844-332-3320 | info@fdazilla.com
Can’t find what you are looking for? Contact us.
SEARCH LESS KNOW MORE
The essential tool for compliance, regulatory, and quality professionals