This module covers the requirements for specifications that must be in place to ensure compliance with 21 CFR 111 and provides guidance on how to establish them.  Specifications for components, ingredients and in-process control points are critical in ensuring that finished product specifications are met.  This module also covers the responsibilities of quality control, the requirements for laboratories and provides guidance for conducting a root cause analysis and implementing effective corrective actions.  The following subparts of 21 CFR 111 are reviewed: o Subpart E – Production and Process Control o Subpart K – Manufacturing Process Control o Subpart F – Quality Control o Subpart J – Laboratory Operations Read more

This module covers the requirements for packaging and labeling systems, applicable even if these are the only operations at your facility.  Also covered in this module are the requirements for warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns.  The following subparts of 21 CFR 111 are covered: o Subpart G – Components, Packaging, and Label Control o Subpart L – Packaging and Labeling Control System o Subpart M – Holding and Distributing o Subpart N – Returns o Subpart O – Complaints   Read more

This module provides a brief historical review of regulations in the dietary supplement industry and their evolution as key incidents exposed health and safety risks to the consumer.  This module also covers the following subparts of 21 CFR 111 which create the foundation of your Quality Management System (QMS) and the good manufacturing practices that control product quality: o Subpart A – General Provisions o Subpart P – Records and Record Keeping o Subpart H – Master Manufacturing Records o Subpart I – Batch Production Record Read more

This course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules, this course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, and investigations; as well as an overview of the relevant subparts. This course also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies the requirements of quality, and describes the purpose of GMP rules, regulations and FDA enforcement. As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Module 1 of this course covers the following requirements of 21 CFR 111: o Subpart A – General Provisions o Subpart P – Records and Record Keeping o Subpart H – Master Manufacturing Records o Subpart I – Batch Production Record Module 2 of this course covers the following requirements of 21 CFR 111: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Module 3 of this course covers the following requirements of 21 CFR 111: o Subpart E – Production and Process Control o Subpart K – Manufacturing Process Control o Subpart F – Quality Control o Subpart J – Laboratory Operations Module 4 of this course covers the following requirements of 21 CFR 111: o Subpart G – Components, Packaging, and Label Control o Subpart L – Packaging and Labeling Control System o Subpart M – Holding and Distributing o Subpart N – Returns o Subpart O – Complaints o The Role of the FDA and its Authority Read more

This eLearning provides an overview of ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management (QRM) and ICH Q10 Pharmaceutical Quality System (PQS).  It summarises the key principles and benefits that accrue with the effective and collective implementation of ICH Q8, 9 and 10. Each section concludes with a short quiz to test your knowledge and following successful completion of the course, you will be issued with a certificate. Read more

This one hour eLearning course is an introduction to the regulations governing the labeling of dietary supplements. This course focuses on how to create a compliant dietary supplement label as required by the FDA and FTC.   Read more