This one-hour eLearning course will focus on the cGMP requirements and other aspects of 21 CFR 117 required for the dietary supplement industry.   Dietary supplement manufacturers may be exempt from the preventative control requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this course, the elements of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers will be highlighted.  Read more

This online self-paced eLearning course provides comprehensive instruction on General Drug or Pharmaceutical cGMPs and Quality Systems. The program is presented in three modules. Each Module is between 1 to 2.5 hours in duration.  The course is approximately 6 hours total including a comprehensive exam at the end of each module. Students must receive 80% on the comprehensive exam. Upon successfully completing the exam, students will print individual course completion certificates to be included as evidence of competency in their training files The on-demand bundled course series includes the following modules: 1. Introductory Topics - approximately 1 hour Provides the history of GMPs and Basic Food and Drug Law to include discussion about USP, NF, Code of Federal Regulations, the FDA and the FD&C act. This section also outlines basic concepts of Pharmaceutical Quality Systems and GMPs, explaining basic principles of a Quality Management System in relationship to the commercial product lifecycle. Students will also learn the importance of quality integration and basic concepts of GxPs and QMS principles and the seven principles in pharmaceutical manufacturing throughout the lifecycle of each product. 2. Intermediate Topics - approximately 2.5 hours This section includes instruction on: •    Quality Culture •    Quality Systems •    People •    Data Integrity •    Documentation and Records •    elements of Procedure and GMP •    Fundamental of GDP Requirements, Materials Management Controls •    Change Management •    Change Control •    Continuous Improvement 3. Advanced Topics - approximately 1.5 hours This section includes instruction on •    Quality Risk Management •    Measuring Success: GMP •    Audits and Self Inspection •    Batch Release System •    Deviation and Human Error •    Complaints •    Quality Defects and Recalls   *Time is approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read more

This course provides a comprehensive overview of Australia’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Australia is utilizing MDSAP.   Read more

This course provides a comprehensive overview of Brazil’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Brazil is utilizing MDSAP. Read more

This course provides a comprehensive overview of Canada’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Canada is utilizing MDSAP. Read more

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers. Read more