Part of PTI’s new online biopharmaceutical and biosimilar CMC analytical series, this course will provide you with the technical know-how required to understand and select the right method verification, qualification and validation. During the 4 weeks, you will review the major life cycle elements and deliverables for biopharmaceutical and biosimilar products.
In addition, you will learn about the quality, regulatory and monitoring aspects for different types of product reference standards and critical assay reagents.
This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.
PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Once you have registered you will be given login details to access the course