BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
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!
Takeaways
- Gain a comprehensive understanding of cGMP by exploring its definition, importance, and historical context.
- Identify the global regulatory bodies that enforce cGMP and familiarize yourself with the laws and publications governing this crucial manufacturing practice.
- State the specific requirements of each cGMP pillar.
- Explain the challenges involved in implementing cGMP and list the strategies to overcome them.
- Analyze real-world case studies to identify non-compliance issues and develop effective corrective actions to ensure compliance in manufacturing operations.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
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