Thursday, 18 January 2018, 11:00AM-12:00PM EST
How to Survive a Regulatory Mock Inspection: A Case Study in What Not to Do
Presented by:Penelope Przekop
Description: According to data from the Office of Scientific Investigations (OSI, CDER), FDA conducted close to 8000 inspections in total and inspected almost 4000 clinical investigators between FY 2005 and 2014. In the same period, a total of 515 inspections were performed at sponsors, sponsor-investigators and Contract Research Organizations (CROs).
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. In 2016, an FDA mock inspection of a large pharmaceutical company was conducted resulting in a mock FDA 483 that included three key observations. The mock inspection resulted in numerous lessons learned by the Sponsor and also the Mock Inspectors that can benefit the industry as a whole.
The webinar will provide lessons learned from this case study as well as other recent mock inspections conducted by industry consultant, Penelope Przekop.
RQAP Re-registration units: 0.25 GCP or GLP