Course description
CMC Analytical, Comparability & Stability Testing and Lab Practices for Biotech and Biosimilar Products
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
Training Course Content
The Primary topics for this Advanced CMC Analytical, Comparability and Stability Studies include:
- Critical elements in establishing reliable, meaningful product specifications for biotech products
- Examples of method lifecycle studies including what should go into written procedures for characterisation/comparability methods
- Kinds of physical and chemical forced degradation studies are applicable to biotech/biosimilar products
- Challenges of devloping and validating process-specific host cell protein assays
- Critical technical aspects of assessing biotechnology product comparability
- Biotechnology reference standards and materials: types and uses
Course delivery details
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3.5 hours online.
Over 2 weeks students will learn through:
- Live interactive bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
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
Reviews
Average rating 4.9
The course trainer was very knowledgeable and covered topics to a good level of depth
Nadine was very good and really went into a lot of detail. I really liked the fact we were given USB sticks with the course content. Excellent course!
Expenses
Receive 10% off bookings for 3-4 courses
Receive 15% off bookings for 5+ courses when booking through our training consultants
Save £240.00 when you book by 20 July 5:00pm
It was great that there were real life examples and thr trainer conveyed their ability to teach the class well on the topic