Managing Your FDA "483" Inspectional Observations 2017

Topics

• How to interpret the 483 - "How bad is it?"
• What the 483 means
• Responding to the FDA in writing
• Managing the 483 discussion with the FDA at the conclusion of the inspection
• What to expect during the next FDA inspection
• Use of a Corrective and Preventive Action program

Who should Attend

• FDA Consultants
• Manufacturers
• Regulatory Affairs Managers
• Legal Counsel
• Operations Directors
• Quality Assurance Staff