Dietary Supplement GMPs: Compliance Expert Demystifies FDA's 1,300-Page Final Rule
$397.00
Product Details
Held Sept. 11, 2007
At last! The FDA has finally released the long-awaited rule on GMPs for dietary supplements. Now what? With 1,300 pages of new manufacturing requirements to read, digest and put into action, is there an easy way to deal with all this?
You bet ...
In this essential 90-minute audio CD/transcript, dietary supplement expert Ivan Wasserman will describe the most important elements of the new rules and what they mean in practical terms. He will save you valuable time with a thorough explanation of the new rule and he will offer valuable strategies to help you be in compliance with these requirements.
Order now for your entire team to listen and discover:
- What companies must do to determine and ensure identity, purity, strength and composition to FDA standards
- What records must be kept
- How they must be maintained and updated
- FDA expectations for complaint handling and adverse event reporting
- Documentation and follow-up
- Exemptions to the rule and how can companies request them
- Timelines for compliance — when companies must be prepared for inspections