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 Japan’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 Japan is utilizing MDSAP. Read more

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