Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies

This training program will provide attendees with a better understanding of the current audit techniques used by FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues. Additionally, the webinar will provide an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited GMP deficiencies over the last several years.

Why Should You Attend:

The success of getting through any audit by federal regulators and third party audits 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 at changes in the FDA’s 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 three years (2012-2015) 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.