Mitigate the Risk of Receiving FDA 483 Observations, Leading to Warning Letters – Your Guide to a Preventative Approach

In this webinar we ask the FDA:

• What is an FDA 483 observation and warning letter?
• What is the FDA typically looking for during an audit?
• How likely is your company to receive a FDA 483 and what are the most common reasons why letters are issued?
• What should companies do if they receive an FDA Form 483?
• What are the top tips for responding to warning letters – with guidance on what to do and what not to do.
• What can companies do to prevent receiving an FDA Form 483 or warning letter?

• Eileen Sullivan-Scully, Senior Sales Executive
• Christian Fortunel, Vice President
• Siobhan Fleming, Business Development Manager
• Keith Bowen, General Manager

• Robert Lewis, FDA Consultant, IHL Consulting Group