Course description
Preparing the Quality Module of the CTD
The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is arguably the most challenging aspect of regulatory approval and requires considerable expertise to navigate it successfully. This detailed, 10 module course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 of your application and will show you how to compile this important part of your submission dossier.
Once completed you will have the skill and confidence to complete the Module 3 section of the CTD, and ensure the correct structure is maintained enabling you to work more effectively with regulators. Importantly, you will learn best practices to complete the Module faster and overcome regulators' questions to fast track submission times and get your products to market quickly.
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Upcoming start dates
Suitability - Who should attend?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/ Officers/ Assistants
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Qualified Persons
- Key contributors to the submission package
Outcome / Qualification etc.
- Compile and submit the Quality and Pharmaceutical section of your registration dossier
- Ensure all data needed has been collected and is suitable for development and manufacturing groups
- Deal effectively with Regulators: Meeting the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
- Incorporate Quality by Design into your CTD requirements and create the optimal Module 3
- Understand the regulatory legal framework and influences on your Module 3 style
- Build Module 3 (CTD) of the dossier to meet regulatory requirements
- Know the legal framework and guidelines for the CMC/Quality part of the dossier
Training Course Content
- Module 1: CMC in the Drug Development Programme
- Module 2: Module 3 & Quality Overall Summary
- Module 3 structure & Quality overall summary (QOS).
- Module 3: Preparing the Drug Substance section of the application
- Module 4: Essential information from API suppliers
- Module 5: Meeting manufacturing and inspection requirements
- Module 6: Writing the section on manufacture of the drug product and process validation section
- Module 7: Writing the sections on control of the finished product
- Module 8: Module 7 Specifications
- Module 9: Stability Section
- Module 10: Pharmaceutical Packaging
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5