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

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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.

Speaker
Instructor: Katherine Giannamore
Product ID: 702756
Training Level: Advanced

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:

Who Will Benefit:

Instructor Profile:

Ms. Giannamore, principal attorney at the Law Office of Katherine Giannamore, P.A., helps individuals and companies resolve a wide range of regulatory issues. In addition to helping clients ensure compliance with the laws and regulations pertaining to food labeling, she serves an international clientele in the development of an array of compliant marketing materials, including websites, brochures, infomercials and more. In addition to these services, Ms. Giannamore helps companies who have been targeted as a result of non-compliance by working on their behalf to secure the release of seized goods, submission of reconditioning requests, effectuating removals from import alerts and providing responses to warning letters. In addition to foods, Ms. Giannamore provides regulatory assistance to the many different FDA-regulated industries, including medical devices, cosmetics and drugs. Katherine Giannamore is currently licensed to practice law in the State of Florida and is admitted to practice before the United States Courts of Appeals for the Third Circuit and the Eleventh Circuit.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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Testimonials:
I am glad that I decided to join the very informative webinar. It included “Must Know” topics and covered FDA requirements for serious adverse event reporting for dietary supplements as well as clarifying the FDA definition of what constitutes a serious adverse event and how to report them. The presentation was updated to include recent developments including the Government Accountability Office report of March 2013.
- Anonymous

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Training Options Training Duration = 60 Min
$249.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$549.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days