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

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. However, the FDA does not provide much guidance on how to qualify vendors. This class is designed for people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. Instructor: Jennifer Alfrey Note : A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you compete your registration.  Certificate of participation are not issued for recorded courses​. 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. 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