Upcoming Sessions

  • There are no upcoming sessions scheduled
See All Upcoming Sessions

This module provides specific guidance on protecting dietary supplement products from contamination and adulteration during the manufacturing process.  It identifies the most common sources of contamination and how to prevent.  This module covers the following subparts of 21 CFR 111 with insights on how to design your quality program, facility and equipment to assure that finished product specifications are met: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Read More

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 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

Join us for this 1-hour training introducing the regulations governing the labeling of dietary supplements. This convenient online training focuses on how to create a compliant dietary supplement label as required by the FDA and FTC. At the end of this course you should be able to: · Identify the parts of a dietary supplement label that are mandated by the FDA · Understand how to structure a Supplement Facts table to ensure that it complies with the new labeling changes · Know the different kinds of claims available to you, and the criteria to use them · Avoid common labeling mistakes made by the dietary supplement industry · Know where to locate the resources available to you when generating a new dietary supplement label Instructor: Erin Taraborrelli Please note, a PDF of the recording will not be distributed. You will have access to the recording for 15 days once you've registered. Certificate of participation are not issued for recorded courses​. Read More

Shopping Cart

Your cart is empty