SOP and Record Keeping for Compliance to 21 CFR 111

About this course

Through the Current Good Manufacturing Practices for Dietary Supplements Regulations that were enacted in June of 2007, the Food and Drug Administration has established industry-wide standards to ensure identity, purity, strength, and composition of manufactured dietary supplements. The regulations are specific with respect to the procedures that must be in place, and the records that must be maintained in support of those procedures; however, they are somewhat vague and don’t offer clear guidelines for achieving compliance. In addition, companies are left to determine the level of compliance that they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations.

Who Should Attend

This course is a must for employees at all levels involved with any activities associated with manufacturing, packaging, labeling or holding dietary supplements; as well as employees involved with the activities of quality control, quality assurance, packaging, labeling, and distributing dietary supplements in the U.S.

Course outline

What You Will Learn

The one-day, “SOPs and Record Keeping for Compliance with 21 CFR 111” course addresses all 16-Subparts of the GMP regulations. In addition, participants in this course will also benefit from discussions of other important-to-know topics not covered in the regulations such as allergen control and product recalls. This information-packed course is designed with recommended and accepted best industry practices for what you must do, and how often you must do it in order to stay in compliance.

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns..

Venue

Salt Lake City, UT - Little America Hotel

Little America Hotel is conveniently located on 10 acres in the heart of downtown Salt Lake City, just 10 minutes from the Salt Lake International Airport. Nestled between the Wasatch and Oquirrh Mountain Ranges in the magnificent Salt Lake Valley, Little America is within walking distance from shopping, restaurants, cultural and sporting events, and is roughly 30-40 minutes from the major ski resorts. Other nearby attractions include historic Temple Square, the world-famous Great Salt Lake and national parks, forests, and monuments.

Venue Address and Contact Details

500 South Main Street
Salt Lake City,
Utah 84101

Telephone: 801-596-5700
Fax: 801-596-5911
Reservations: 800-281-7899

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our expert for this course is:

• Manny Jimenez
  BSc Chem, MS Chem
  

  • [email protected]
  • +1 857 350 4788

What you've said

“NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”

Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)

“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”

Kim Randall Pearson, General Counsel, Thorne Research, Inc.