"An excellent course which answered a lot of questions and concerns"
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PRACTICAL SESSIONSWhat are the expectations for heterogeneity in biotechnology products?
DISCUSSION SESSIONSdiscussion of ongoing resources for biotechnology analytical CMC issues
COMPREHENSIVE OVERVIEW...of all relevant regulatory, technical and wuality elements necessary to assure successful design
KEY DELIVERABLES...from each phase of development will be illustrated.
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.
This course will provide attendees with a clear, 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 emerging 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.
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
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals