This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.
This session is designed for manufacturers and labelers of dietary supplement products and is designed to aid both domestic and foreign entities in ensuring compliance with FDA regulations. This session will cover the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act and accompanying FDA regulations.
Why Should You Attend:
Manufacturers, packers and distributors of dietary supplements and nonprescription drugs in the United States are required under federal law to submit reports of serious adverse events. Federal law and FDA regulations dictate the precise requirements as to whom, when and how this information must be submitted. In addition, federal law sets forth the recordkeeping requirements for manufacturers, packers and distributors of dietary supplement products.This session is designed for manufacturers and labelers of dietary supplement products and is designed to aid both domestic and foreign entities in ensuring compliance with FDA regulations. This session will cover the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act and accompanying FDA regulations.
Areas Covered in the Webinar:
- Detailed overview of the Dietary Supplement and Nonprescription Drug Consumer Protection Act
- Overview of the products and parties subject to reporting and recordkeeping requirements under federal law and FDA regulations.
- Examination of 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.
- How to properly submit a serious adverse event report to the FDA, including an overview of the minimum data elements.
- Detailed explanation of the recordkeeping requirements applicable to all responsible parties.
- What FDA expects from manufacturers and labelers.
- How failure to comply with the guidelines may affect the manufacturing unit.
Who Will Benefit:
- Dietary supplement manufacturers and facilities responsible for packaging, labeling and distributing dietary supplement products
- Regulatory Affairs
- Documentation
- Senior Management
- Risk Managers
- Legal
Course Provider
Katherine Giannamore,
