Putting the “Good” back in “Good Laboratory Practice”
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many …
Entries by Maria
Data Integrity Highlights from the PDA/FDA Joint Regulatory Conference
The time has come for us to talk about the Data Integrity elephant in the GMP room. Despite Data Integrity being a hot topic in industry for the past 5 years, it continues to …