Dietary Supplement Testing and Specifications Seminar

Since the FDA’s dietary supplement cGMP regulations (21 CFR Part 111) were published, specifications and testing have been consistently one of the most frequently cited FDA observations. Part 111 has very specific requirements for components, in-process, packaging and labeling, and finished product specifications and requirements to perform testing to ensure those specifications are met. This course will address the regulatory requirements and EAS’s expert interpretation, including recent regulatory action. It will also cover frequently asked questions around reduced testing, if “by input” is acceptable, and finished product rotational testing plans.