Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2013

Topics

• Products and parties subject to reporting and recordkeeping requirements under federal law and FDA regulations
• Dietary Supplement and Nonprescription Drug Consumer Protection Act
• Submit a serious adverse event report to the FDA, including an overview of the minimum data elements
• How "serious adverse event" and "adverse event" are defined under the law and how understanding this distinction is critical to knowing when reports must be submitted to the Agency
• What FDA expects from manufacturers and labelers
• The recordkeeping requirements applicable to all responsible parties
• How failure to comply with the guidelines may affect the manufacturing unit

Who should Attend

• Regulatory Affairs
• Dietary supplement manufacturers and facilities responsible for packaging, labeling and distributing dietary supplement products
• Senior Management
• Documentation
• Legal
• Risk Managers