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

This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.   Please note, the course will be made available for 30 days from the date of purchase Read more

Bundle of 6 Courses - ISO 13485:2016 Overview and Country-Specific Medical Devices Regulatory Requirements for United States, Japan, Australia, Brazil, Canada A comprehensive overview of each country's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements. This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement. Read more