Drug Product registration process in the US MasterClass

Topics

• What are the possible types of FDA Audits based on scope
• FDA structure and its methodologies on submissions evaluation
• How to organize the upcoming inspection
• How to assess the status of the plant and reach the adequate level for the FDA audit
• Management of the response to audit observations

Who should Attend

• Quality Assurance
• Quality Control
• Engineering
• Manufacturing
• CSV
• IT
• TR&D
• Regulatory Affairs