The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides a template for companies to analyze their own practices and ensure similar issues have been 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 FDA’s approach to audits and the current method used to determine audit frequencies by using a system of risk assessments.
Within the industries of pharma, biotechnology and medical devices, the word ‘audit’ can cause anxiety when you are unaware of how your company’s practices and procedures compare to the rest of the industry. Part of successfully getting through a regulatory audit involves: knowing the applicable regulations, the audit approaches used by regulators, and the common areas of industry deficiencies.
In addressing all these key elements, this webinar will:
Provide attendees a better understanding of the current audit techniques used by the FDA and how they have changed over the years
Analysis of the top 10 most cited GMP drug manufacturing deficiencies over the last year
Review of the significant increase in the number of warning letters issued over the last four years
Review common areas of focus during audits
Provide a template that companies can use to evaluate their own state of compliance
Demonstrate examples to highlight various points discussed
Areas to be Covered:
Changes in FDA audit approaches
Areas of focus during audits
Most commonly cited drug GMP deficiencies for 2012-2013
Increase in FDA enforcement actions
Interactive Q&A Session
Who will Benefit: