Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2013
04 Apr 2013
Webinar
Key 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
Past Events
Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2013 - 04 Apr 2013, Webinar (36673)
Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2026
Important
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