New
Certification
CMC Regulatory Essentials (Team Package)
About this Course
Build and defend the quality part of your dossier, from development data to post-approval changes.
A team package: bought once by your company and used by every colleague who needs it, from 3 participants. Delivered as live virtual, workshop, assessment, with 5 modules and about 15 hours of training per participant.
See plans, the buying process and how to request a proposal on the Team Training Packages page.
What You Will Achieve
This package covers:
- CMC regulatory framework: ICH Q8–Q14 and regional requirements
- Drug substance and drug product development data
- Specifications, analytical procedures and stability (ICH Q1, Q2, Q6)
- Writing eCTD Module 3 and responding to deficiency letters
- Post-approval changes and lifecycle management (ICH Q12)
Target Audience
Regulatory affairs, development, QA, technology transfer.
Bookable for teams: Team plan (3–9 participants), Department (10–24), Enterprise (25+) or In-house at your site.
Program Outline
| Module | Topic | Duration |
|---|---|---|
| 1 | CMC regulatory framework: ICH Q8–Q14 and regional requirements | ~3 h |
| 2 | Drug substance and drug product development data | ~3 h |
| 3 | Specifications, analytical procedures and stability (ICH Q1, Q2, Q6) | ~3 h |
| 4 | Writing eCTD Module 3 and responding to deficiency letters | ~3 h |
| 5 | Post-approval changes and lifecycle management (ICH Q12) | ~3 h |
Registration Fee
Price on request
30-Day Money-Back Guarantee
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Start Date Dates to be announced
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Location Team Package
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Language English
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Certificate Official Certificate of Completion
