Course description
Regulatory and Compliance Requirements for CMC Analytical Studies
The course will provide you with regulatory and compliance clarity to ensure your analytical practices meet global requirements. Over 4 weeks you will learn what studies are needed and, crucially, when they must be completed to minimise development delays affecting your protein products (breakthrough or biosimilar).
In addition, you will gain best practice as you transition from R&D laboratory analytics to GxP requirements gaining an appreciation of the data required and the risks involved.
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Suitability - Who should attend?
This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.
Outcome / Qualification etc.
- Discover the global regulatory requirements for CMC biologics
- Learn what CMC data sets are required for all protein products, including biosimilars
- Examine when CMC analytical studies must be conducted during development
- Understand the CMC timelines for biosimilar and biopharmaceutical breakthrough products
- Learn best practice for taking your R&D laboratory work to GxP standards
- Explore the GxP requirements for analytical CMC biologics
- Discover the common R&D quality and documentation issues with biopharmaceutical and biosimilar products
Training Course Content
- Module 1 - 3 : Regulatory Basis of CMC Analytical Requirements for Biological Products: Doing the Right Things at the Right Times
- Module 4 - 6 : Dossier R&D Data versus GxP Data: Analytical Lab Quality Practices from R&D to GxP
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
Good introductory training.