Date : Tuesday, June 28, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 60 Minutes Price : $245.00
Live Webinar Adverse Event Reporting for Dietary Supplements and OTC Drugs
Overview: Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs.
Register Now Instructor Profile: Norma Skolnik Senior Consultant, EAS Consulting
Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to answer.
Norma Skolnik has 30 years of regulatory experience in the OTC Drug, Food and Dietary Supplement industries. She has had extensive Why Should You Attend: There are often questions about experience advising on regulatory what FDA considers to be an adverse event and about strategies for new and marketed Adverse event reporting requirements for Dietary consumer healthcare products. Supplements and OTC drugs. This Webinar will help to answer Particularly regarding the those questions and will help assure manufacturers and development and review of optimal importers that they comply with the law. product claims and advertising. For 10 years, Norma served as Director Areas Covered in the Session: of Regulatory Affairs for Cadbury Adams, Americas (formerly Adams Division of Pfizer). ...more l Adverse event reporting and recordkeeping requirements of the Dietary Supplement Related Products &Nonprescription Drug Consumer Protection Act l Questions & Answers regarding the Labeling of Dietary ISO 13485 Gap Analysis Toolkit Supplements as required by the Dietary Supplement ISO 13485 Quality Manual and Nonprescription Drug Consumer Protection Act
Click here to register for this webinar
Intro to ISO 13485 Presentation Materials ISO 13485 Internal Auditor Checklist
Who Will Benefit: l l l l
Regulatory Professionals Drug Marketers Manufacturers and Distributors Students of FDA Regulations
Your Necessity is our Priority
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec.