Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Af Read more
In this
Course Objectives:
• To understand basic Dietary Supplement regulatory requirements
• Learn about Dietary Supplement Labeling compliance
• Convey
• Explain FDA Requirements for Dietary Supplement GMPs
• Understand FDA Serious Adverse Event Reporting Requirements
• Convey an understanding of how to avoid FDA Warning Letters
Course Outline:
• Background to Dietary Supplement regulations
• Dietary Supplement Labeling Requirements
• New Dietary Ingredient Requirements
• FDA Reporting requirements for Serious Adverse Events
• Dietary Supplements GMP regulations
• Advertising & Promotion of Dietary Supplements
• Importing Dietary Supplements into the U.S.A.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Dietary Supplement Business Owners
• Regulatory Affairs professionals
• Quality Assurance managers
• Dietary Supplement Marketing managers
• Audit and Compliance Personnel
• Anyone in the Consumer healthcare and