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 course provides a comprehensive overview of the United States 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 the United States 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 one-hour self-paced eLearning course provides essential GMP refresher training required for all individuals involved in the manufacture and supply of medicinal products.  It provides a reminder of the different regulatory organisations globally that are responsible for defining Good Manufacturing Practice requirements, as well as a reminder of the Golden Rules of GMP.  It highlights the most frequent regulatory inspection findings against cGMP from both the FDA and MHRA, as well as providing an enhanced focus on data integrity.  It concludes with providing an overview of those evolving areas of GMP, such as CSV and the impact of digital solutions (AI and ML), regulatory focus on security of supply and the impact on the environment. This course includes a competency assessment that, with successful completion, leads to a certificate of completion.  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