Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2013 is a webinar that covers topics such as:
- 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
Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act 2013 brings together:
- Regulatory Affairs
- Dietary supplement manufacturers and facilities responsible for packaging, labeling and distributing dietary supplement products
- Senior Management
- Documentation
- Legal
- Risk Managers
