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

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 one-hour self-paced eLearning course is designed for regulators and professionals in virtual pharmaceutical companies. It focuses on essential Good Manufacturing Practices (GMP) and compliance strategies. By the end of the training, participants will be able to describe the responsibilities of the Marketing Authorization Holder (MAH) and the Manufacturing Import Authorization (MIA) holders, understand and implement quality culture principles, manage outsourcing effectively, and navigate the challenges of batch release in a virtual environment. Additionally, learners will gain insights into data integrity practices and stay updated with the latest regulatory changes. 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