The quality of pharmaceutical products is subject to rigorous scrutiny and meticulous control because anything less than the best possible quality could result in regulatory issues. More importantly, compromised quality could jeopardize patient safety, leading to potentially serious health risks. Current Good Manufacturing Practices (cGMPs) are regulations (21CFR210-211) used to ensure consistency in the manufacture of quality healthcare products. These regulations involve various departments in the manufacturing process.
As consumers of pharmaceutical products, whether they are prescriptions (“RX”) or over-the counter (“OTCs”), we expect them to be safe, pure, and effective. It is up to those manufacturing and testing these products to ensure that current good manufacturing practices (cGMPs) are followed from the acquisition of raw materials to the distribution of the final dosage forms. Health authorities like the US Food and Drug Administration (FDA) periodically conduct inspections of facilities to ensure that the cGMP regulations are implemented and followed.
In this 90-Minute accredited training, participants will be provided an overview to GMPs for pharmaceuticals and the current U.S. FDA regulations. Seven Essentials of GMPs and examples of compliance versus non-compliance will be covered as well as the consequences for non-compliance.
Upon completion of this course, you will be able to:
COURSE OUTLINE
Where did the GMPs come from? Why do they exist?
What makes for “current” good practice?
Seven Essentials of GMP
Examples of non-compliance
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This course is designed for quality professionals, production and manufacturing technicians, packaging, distribution, and labeling staff, validation staff and any other sponsor organization representative that contract to GMP vendors and needs to understand the regulations.
This course is also for any others looking to enter the GMP sector or within the following industries:
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