cGMP Primer

cGMP Primer introduces the benefits and challenges of current Good Manufacturing Practices. The first section sets the stage with the regulatory bodies that enforce cGMP worldwide and the laws that pertain to it. This class takes a deep dive into the six cGMP pillar requirements, including Quality Management System (QMS), Premises and Equipment, Personnel Training, Materials Management, Documents and Records, and Validation and Qualification. This primer ends with a focus on regulatory audits, the Establishment Inspection Report (EIR), non-compliance, and remediations such as a 483. Two real-world case studies provide the opportunity to showcase your newfound knowledge by identifying the non-compliance and determining the corrective action. Take your spot for this introductory cGMP course!

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