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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 course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules, this course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, and investigations; as well as an overview of the relevant subparts. This course also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies the requirements of quality, and describes the purpose of GMP rules, regulations and FDA enforcement. As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Module 1 of this course covers the following requirements of 21 CFR 111: o Subpart A – General Provisions o Subpart P – Records and Record Keeping o Subpart H – Master Manufacturing Records o Subpart I – Batch Production Record Module 2 of this course covers the following requirements of 21 CFR 111: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Module 3 of this course covers the following requirements of 21 CFR 111: o Subpart E – Production and Process Control o Subpart K – Manufacturing Process Control o Subpart F – Quality Control o Subpart J – Laboratory Operations Module 4 of this course covers the following requirements of 21 CFR 111: 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 o The Role of the FDA and its Authority 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

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