21 CFR Part 111 - Specification Requirements

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.

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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.

Areas Covered in the Webinar:
  • Define the six specification categories.
  • Define what each category must contain.
  • Translate the requirements into a workable document.
  • Determine how to establish a specification and a COA should contain.
  • Provide different examples of specifications and acceptance criteria.
  • Determine specification approvals.
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
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.

Refund Policy

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.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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