Course description
Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier - Online Academy
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 theCTD, and ensure the correct structure is maintained enabling you to work more effectively with regulators. Importantly, you will learn best practice 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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Suitability - Who should attend?
This course is suitable for:
- 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.
Training course content will include:
- Compiling and submitting the Quality and Pharmaceutical section of your registration dossier
- Ensuring all data needed has been collected
- Ensuring suitability of data from your development and manufacturing groups
- Dealing effectively with Regulators: Meeting the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
- Incorporating Quality by Design into your CTD requirements and create the optimal Module 3
- Understanding the regulatory legal framework and influences on your Module 3 style
Training Course Content
- Module 1: CMC in the Drug Development Programme
- Module 2: Module 3 & Quality Overall Summary
- 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
- 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
The trainers for the course were very friendly and clearly very knowledgeable. I found the flexibility of the course and the structure very useful to fit around my schedule.