Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current Good Manufacturing Practice (cGMPs) regulations.
This course will discuss the FDA regulations 21 CFR Subparts J&K addressing the words and meaning as they apply to the US Pharmaceutical Industry. The course will show how these paragraphs are to be interpreted and how one should comply.
Upon completion of this course, you will be able to:
This training is part of the 10-course series required for the Cobblestone GMP Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.
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This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas.
Engineers, chemists, QA/QC and manufacturing personnel will greatly benefit from attending this course by understanding the extent of FDA regulations and how they affect daily job responsibilities.
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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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