This course provides a “how to” guide for implementation of the FDA GMP requirements in the 21 CFR (Code of Federal Regulation) Part 111. These FDA regulations effect ALL companies involved with the manufacturing, packaging, labeling, and holding of dietary supplements!
Topics include: methods of botanical identification; terminology included within this code; and the necessary documentation to support the packaging and quality control of botanical dietary supplements. Examples of required documentation records will be discussed and generic templates for this documentation will be provided.
Each student will prepare an herbal tincture following GMP procedures and documentation.
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