- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products
18 May 2013
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CMC Analytical, Comparability and Stability Studies for Biotechnology Products
Course Objectives
This practical 2-day training course presents all of the regulatory, technical and quality elements necessary to produce successful analytical test methods, product reference standards, comparability studies and stability protocols for biotechnology products in the US and EU.
What Will You Learn?
Clarify the latest CMC regulatory requirements for biotech products to ensure successful marketing applications
Assess comparability and stability considerations for biotech product specification
Design and develop your biotech stability protocols by identifying the key practical details to address
Validate your stability testing methods appropriate for each phase of development
Identify which characteristics of a biotech product require analytical assessment
Follow the ICH, FDA and USP guidelines for analytical method validation
Identify and implement key considerations for biotechnology laboratory testing
Why you should attend
- Create compliant stability protocols
- Ensure EU and FDA regulatory compliance
- Identify specifications for release
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Who Should Attend
This training course is intended for the professional who is 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
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Dates and Venues
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