Responding to FDA 483s and FDA Warning Letters - Can you afford not to be prepared?
Instructor : Angela Bazigos
Aug 01, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
A fun way to present this serious topic!! Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility.
483's and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there were 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared?
In this webinar you will learn How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters, How to respond to 483s and Warning Letters to avoid escalation by the FDA.
Areas Covered in the Session:
- Why the FDA issues such citations
- What is a 483 and what does it look like
- What is a Warning letter and what does it look like
- What is the difference between a 483 and a Warning Letter
- What they mean for your company
- How to respond to 483s and Warning Letters to avoid escalation by the FDA
- How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters
Who Will Benefit:
- Regulatory Professionals
- Quality Professionals
- Regulatory Affairs Professionals: Quality Managers, Quality Engineers, Small Business Owners, GxP Consultants