11-20 August 2020
LIVE Online Academy,
4 sessions delivered over 2 weeks
Advanced CMC Analytical Studies and Lab Quality Practices
Undertake a deep strategic analysis of biopharm CMC studies to increase efficiency and reduce costly non-compliance delays
For biotech and biosimilar products
Live Online Academies
In light of the uncertain times we’re facing at the moment, 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 hours online.
All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.
Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org, or you can see other live online academies here.
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.
What will you learn?
Ascertain the main elements which are critical for establishing reliable and meaningful product specifications for biotech and biosimilar products
Characterization and comparability
Review examples of method life cycle studies including what should go into written procedures for characterization and comparability methods
Examine what kinds of physical and chemical forced degradation studies are applicable to biotech and biosimilar products
Overcome the challenges of developing and validating process-specific host cell protein assays
Explore different types and uses of biotechnology reference standards and materials
Who is this course for?
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
The analytical side of CMC with course leader, Nadine Ritter
Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.