21 CFR 111 GMP Dietary Supplement in Spanish– Recorded Session

About This Course

The FDA expects all companies that manufacture, package, or store dietary supplement products to follow 21 CFR 111, Current Good Dietary Supplement Manufacturing Practices (cGMP). Combining extensive industry experience and a concrete understanding of regulations with flexible and convenient training, this course provides a solid understanding of cGMPs and the responsibilities expected of various individuals and groups within the company. You will learn how to apply cGMP principles to specific situations.

This dietary supplement GMP training course provides an overview of subparts A-P of Regulation 21 CFR 111, including:

  • Specs, Manufacturing Master Records/Batch Production Records
  • Quality Authority and FDA Warning letters
  • How to make sense of complex regulations in an understandable and comprehensive way
  • How to effectively turn regulations into real-world examples and scenarios, delivering clarity and operational success
  • How regulations can be applied to your organization cost-effectively

Key Learning Objectives:

At the end of this course, you will understand the following:

  • Basic requirements of the cGMPs
  • Details of cGMPs as they relate to:
  • Personnel
  • Buildings and facilities
  • Equipment
  • Facility records
  • Production and process control
  • Holding and distribution
  • Batch records
  • Packaging and labeling
  • Quality control and quality assurance
  • Laboratory operations
  • Product complaints
  • The purpose of guidance documents
  • The role of the FDA and their authority
  • The roles and responsibilities of the quality unit

Who Should Attend?

Attend this training if you work in:

  • Management
  • Manufacturing
  • Quality control/assurance
  • Packaging
  • Marketing
  • Laboratory operations
  • Auditing
  • Suppliers and distributors
  • Regulatory affairs

Please Note: Once you've completed your registration, you will have access to the recording for 30 days. A PDF of the presentation will not be available. Certificate of participation are not issued for recorded courses.

Price: $499.00

Length: 10 Hours

Difficulty: Intermediate

Instructor: Carlos Alvarez