data integrity

/Tag:data integrity
9 04, 2015

Data Integrity: The Whole Story

By | 2017-11-06T01:19:57+00:00 April 9th, 2015|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Inspections, Form FDA 483, quality assurance|

Barbara Unger has shared about the new regulatory expectations regarding GMP Regulatory Intelligence.  Indeed, we have heard that FDA inspectors have started asking people about what processes they have in place to monitor new regulations, guidelines, and developments.  In part, this is why we offer the GMP Regulatory Intelligence newsletter. Now, we go deep into a serious issue that has received [...]