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.
Live Online Academies
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.
During these sessions students will learn through:
- 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
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
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
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).
Delegates of our live online academies said...
25% discount on Routledge books
As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.
Examples of books and eBooks within biopharmaceuticals include:
- Fundamentals of Modern Bioprocessing
- Cell Culture Bioprocess Engineering, Second Edition
- PAT Applied in Biopharmaceutical Process Development and Manufacturing
- Process Validation in Manufacturing of Biopharmaceuticals
- Immune Aspects of Biopharmaceutical and Nanomedicines
- Mathematical and Statistical Skills in the Biopharmaceutical Industry
- And more
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.