21 CFR Part 111 - Current FDA 483 Observations and Warning Letters Review

The FDA inspects facilities, online marketing collateral and physical products to determine compliance with the 21 CFR Part 111 dietary supplement regulations. It is very helpful to review their observations to infer what their priorities are and where industries and companies alike can improve. Why Should You Attend:: This course will pull 483 observation and warning letter data directly from the FDA and provide an analysis since the regulations were implemented fully in July 2009. You will see the overarching topics and we will drill down into the data to determine risk and priorities. After the training you will have the necessary knowledge and tools to set quality and manufacturing priorities and confidently meet FDA expectations. Areas Covered in the Webinar: All 483 Observations from 2009 - 2021. All warning letter citations from 2009 – 2021. Analysis of the observations to determine FDA trends. Analysis of the data to determine the state of the industry. Quali... Read more

The FDA inspects facilities, online marketing collateral and physical products to determine compliance with the 21 CFR Part 111 dietary supplement regulations. It is very helpful to review their observations to infer what their priorities are and where industries and companies alike can improve. Why Should You Attend:: This course will pull 483 observation and warning letter data directly from the FDA and provide an analysis since the regulations were implemented fully in July 2009. You will see the overarching topics and we will drill down into the data to determine risk and priorities. After the training you will have the necessary knowledge and tools to set quality and manufacturing priorities and confidently meet FDA expectations. Areas Covered in the Webinar: All 483 Observations from 2009 - 2021. All warning letter citations from 2009 – 2021. Analysis of the observations to determine FDA trends. Analysis of the data to determine the state of the industry. Quality and manufacturing priorities based on the data. Who Will Benefit: Dietary supplement manufacturers Dietary supplement brand owners Executives responsible for meeting FDA expectations and 21 CFR Part 111 regulations Employees who will participate in meeting FDA expectations and 21 CFR Part 111 regulations