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.

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Last Recorded Date: Feb-2022

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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
Instructor Profile:
Andy Swenson Andy Swenson

VP of Quality & Product Development, Dietary Supplement Experts, LLC

Andy Swenson has been in the dietary supplement industry for over 25 years. Starting as a machine operator in the encapsulation department back in the mid-90's he quickly fell in love with the industry and its unique approach to providing solutions for people looking for alternative therapies. As his career progressed his expertise shifted from operating machines to product development and, for the last 15 years, quality. In 2009 the 21 CFR Part 111 dietary supplement cGMPs were introduced and he saw this as an opportunity to be on the forefront of developing compliant systems. Since that time, his focus has been on helping companies navigate the regulations while coming up with realistic and budget friendly solutions. Andy has assisted many companies with FDA inspections and responses, consent decree management, and the proactive implementation of required cGMP quality systems. He is currently a consultant at Dietary Supplement Experts and oversees the cGMP compliance sector. Between Andy and Curtis Walcker (his DSE business partner who is responsible for 21 CFR Part 101 labeling compliance), they offer a complete package for dietary supplement companies looking to reduce regulatory risk.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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