The success of getting through any audit by federal regulators is not only dependent on a well prepared training of all staff and department employees, but also in knowing what the focus has been of recent inspections within the industry. Such information provides a template for companies to look closely at their own practices in helping to assure similar findings are adequately addressed. In addition, as the audit techniques of the FDA have changed over the years, knowing what to expect can help establish a focused training program as part of the preparation.
This webinar will look as changes in the FDA'a approach to audits and the current method used by the agency to determine audit frequencies by using a system of "risk assessments”. The top 10 most cited GMP deficiencies for drug manufacturers over the last year will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentation
This webinar will look as changes in the FDA'a approach to audits and the current method used by the agency to determine audit frequencies by using a system of "risk assessments”. The top 10 most cited GMP deficiencies for drug manufacturers over the last year will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentation
