The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.
Why Should You Attend::
Given the different categories, a “one size fits all” approach will not work. Therefore, we must understand how to structure the specifications so that categorical requirements are met while minimizing risk. After the training you will have the necessary knowledge, tools, and templates to establish specifications. Additionally, you be able to set specification priorities so that you can gradually eliminate regulatory risk and confidently meet FDA expectations.
Who Will Benefit:
- Dietary supplement manufacturers
- Dietary supplement brand owners
- Executives responsible for establishing specification programs
- Employees who will participate in creating and implementing specifications
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