Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies Webinar
Time: 10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Kenneth Christie
Learn more about FDA´s current audit techniques and the most commonly cited GMP deficiencies that you have to watch out for. The webinar instructor, an FDA and GMP training expert, will help attendees analyse a system of risk assessments to determine audit frequencies.
The success of an audit by federal regulators does not always depend on the level of training proffered 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.
Why Should you Attend:
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 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
Attendees will also get a chance to present their questions and point of view in an interactive Q&A session at the end of the webinar.
Objectives of the Presentation:
Objectives of the presentation are to discuss about:
- Changes in FDA audit approaches
- Areas of focus during audits
- Most commonly cited GMP deficiencies for 2012-2013
- Increase in FDA enforcement actions
- Questions and answers