Introductory CMC Analytical Studies and Lab Quality Practices (LIVE online)
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products. Key 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.
Suitability - Who should attend?
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
- LIMS Administrators
- QA/QC Reviewers
- Validation Scientists
- Calibration/Metrology Groups
- Internal or Independent Auditors
- Manufacturing/Production Managers
Outcome / Qualification etc.
- Gain a comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products
- Maintain product reference standards and design successful comparability tests
- Examine the different stages of the life cycle including pre-clinical, clinical trials, commercialisation and post-approval
- Design and implement successful comparability tests for biosimilars
- Discuss analytical considerations for a wide variety of biopharmaceuticals including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates)
- Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer
Training Course Content
- Session 1 - Regulatory Basis of Analytical Requirements: Are You Doing the Right Things at the Right Times?
- Session 2 - Technical Considerations in Analytical Method Lifecycles: Do I Have to Validate This Method? If so, By When and How?
- Session 3 - Illustration of Analytical Lab Quality Practices R&D to GxP: What Differentiates R&D Data from GxP Data, and Why Does It Matter?
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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