CMC Primer | CPE

- Level: Beginner
- CPE: 1.0 Credits
- Time: 45 minutes
CMC Primer emphasizes the critical importance of Chemistry, Manufacturing, and Controls data and documentation as outlined within Quality Management Systems (QMS). Three case studies demonstrate how CMC decisions influence a drug’s safety, efficacy, and consistency.
- Understand the critical role of CMC in regulatory compliance
- Gain insight into CMC’s impact on product lifecycle management
- Learn which key CMC data is required for regulatory submissions and post-marketing surveillance
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- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
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CMC: Drug Development Considerations
Explains the role of chemistry, manufacturing, and controls (CMC), and the importance of CMC data for regulatory compliance.
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CMC: In Action
Details the roles of Chemistry for drug purity and stability, Manufacturing for quality and compliance, and Controls for product efficacy and safety.
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CMC: Regulatory Considerations
Examines the pivotal role CMC data plays in ensuring product quality, safety, and regulatory compliance.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
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