2-day live online training course
UNDERSTAND CURRENT AND EMERGING EXPECTATIONS FOR CMC ANALYTICAL STUDIES TO ALIGN WITH REGULATORS AND EXPEDITE THE DEVELOPMENT OF ALL TYPES OF BIOLOGICAL PRODUCTS
Critical-path analytical studies for Accelerated, Breakthrough and Biosimilar Products
Course Overview
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical, and quality elements necessary to assure successful planning and documentation of the required CMC analytical and stability studies for biological products. Key data deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented, based on real-world experiences of Dr. Nadine Ritter supporting hundreds of biological products over more than 25 years.
Meet Your Course Instructor
Dr. Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.
What will you learn?
Phase-specific requirements
Gain a comprehensive overview of the current and emerging regulatory guidances that govern the phase-specific requirements for CMC analytical studies with any type of biological product
Critical path studies
See the rationale behind the critical path analytical CMC studies required throughout different stages of the product life cycle including pre-clinical, clinical trials, commercialization, and post-approval to make effective timeline decisions
Product specifications
Understand the rationale behind setting meaningful, supportable product specifications; learn the key elements to include in biological product analytical control strategies
Method lifecycles
Review the applicable regulations that define phase-specific method validation expectations, and learn best practices for analytical method qualification, validation, verification, tech transfer, and method bridging for all types of methods for biological products.
R&D to GxP Quality Practices
Understand the specific laboratory operational requirements for GxP compliance during product development, and learn the emerging expectations for lab quality and data integrity in R&D labs that generate the CMC data submitted in product dossiers
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.
Over 2 days 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 lifesciences-training@informa.com.
Who is this course for?
This training course is intended for professionals who are involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:
- Stability Directors/ Supervisors/Managers/Analysts/Coordinators
- Laboratory Supervisors/ Managers
- Project Managers/Coordinators
- Quality Control Analytical Chemists
- Research and Development Chemists
- Biostatisticians
- LIMS Administrators
- QA/QC Reviewers
- Validation Scientists
- Calibration/Metrology Groups
- Internal or Independent Auditors
- Manufacturing/Production Managers
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).
CPD Certified
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.