Course description
Advanced CMC Analytical Studies and Lab Quality
Explore the technical challenges to designing and executing specific critical analytical studies with renowned expert Dr. Nadine Ritter. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion of designs and outcomes. Finally, tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given.
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Suitability - Who should attend?
This course would be useful for:
- QC release and stability analysts
- Stability program managers
- Product scientists and test method technical experts (R&D and QC)
- Process analytical chemists and process development scientists
- Quality assurance specialists
- GMP compliance auditors
- Regulatory affairs CMC authors or reviewers
- Analytical and stability laboratory managers (R&D through GMP)
- Project managers with CMC responsibilities
- Business managers with CMC responsibilities
- Key staff from biotech academic incubators and small start-ups
- Contract testing labs
Outcome / Qualification etc.
- Ascertain the main elements which are critical for establishing reliable and meaningful product specifications for biotech and biosimilar products
- Overcome the challenges of developing and validating process-specific host cell protein assays
- Review examples of method life cycle studies including what should go into written procedures for characterization and comparability methods
- Explore different types and uses of biotechnology reference standards and materials
- Examine what kinds of physical and chemical forced degradation studies are applicable to biotech and biosimilar products
Training Course Content
- Session 1:Biological Products CMC Analytical Method Lifecycles: Qualification, Validation, Verification, Transfer, Bridging
- Session2:Analytical Elements of Comparability Studies (Process Changes) and Similarity Studies (Biosimilar Products): Experimental Designs and Challenging Considerations
- Session 3: Key Elements for Assessment and Monitoring of Biological Product Stability
- Session 4: Characterization and Control of Critical Impurities: Host Cell Proteins, Particulates, and Leachables
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
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