Live Streamed Course - Seats Filling Fast!
Next Course Date
October 7 - 10, 2024 Live Streamed Classroom |
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| Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC. a dynamic, innovative quality solutions provider to life science startups and global Fortune 500 organizations who are as passionate as we are about keeping patients safe and delivering quality products.
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Course runs 7:00 to 12:00 ET / 13:00 to 18:00 CET This Good Manufacturing Practices (GMP) training covers the foundations of the regulations that control the manufacture, process and distribution of pharmaceutical products sold in the United States. Application of the regulations in Title 21 CFR 210/211 (Current Good Manufacturing Practices [CGMP] for Finished Pharmaceuticals) will be presented, and both compliance and non-compliance examples are provided throughout the GMP course. Sections of 21 CFR 211 will be interspersed with references from 21 CFR 600/610 (Biological Products: General) and 21 CFR 1271 (Human Cell Tissue Products). |
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All participants will gain a fundamental knowledge of the basis of CGMP regulations, and the necessity of implementing them in daily operations. Additionally, this course is intended to give participants an introduction to the CGMP regulations and their application to laboratory activities, manufacturing processes and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation. |
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