CMC: Chemistry, Manufacturing, and Controls

Master the essentials of Chemistry, Manufacturing, and Controls (CMC) with our certified training course.

Our certified covers key phases from product development and clinical trials to market approval and post-approval management. It provides the essential knowledge and tools to effectively manage CMC requirements, reduce compliance risks during audits and ensure successful product approvals.

Who should enroll?

This course is ideal for professionals in regulatory affairs, quality assurance, pharmaceutical development, manufacturing, and project management who are responsible for ensuring product compliance and regulatory submissions.

Topics outlined in the course:

• Key CMC requirements for clinical trials and marketing applications.
• Effective management of postapproval CMC changes.
• Guidance on preparing and maintaining essential CMC documentation.
• Best practices for ensuring compliance with regulatory agencies.
• Integration of CMC into quality and manufacturing systems.

Each session incorporates real-life examples and practical assessments to ensure a rich, hands-on learning experience. Upon successful completion, participants will be awarded a CMC training certificate, fully recognized during regulatory audits.

Curriculum:

Introductory Video

Lesson 1: General CMC Information

• Chemistry
• Manufacturing
• Controls
• Documentation and Structure of CMC (Common Technical Document (CTD)

Lesson 2: CMC-Specfic Guidance

• International Council for Harmonization (ICH) Guidelines for CMC Submissions
• Implementing ICH Guidelines in CMC Documentation
• Key FDA Guidance Documents Relevant To CMC
• European Medicines Agency Guidance

Lesson 3: CMC for Clinical Trials

• What is an Investigational New Drug Application (IND)?
• CMC Requirements for Phase I, II, and III Clinical trials
• CMC Amendments During Clinical Trials

Lesson 4: CMC for Marketing Applications

Lesson 5: Postapproval CMC

• Regulatory Requirements for Post-Approval changes
• CMC Supplements and Amendments
• Preparing and Submitting CMC Supplements
• Risk Management and Control Strategies

Conclusion

Evaluation