Starts 4 May 2020
6 module series over 4 weeks
Methods and Reference Standards for CMC Analytical Studies
Gain a comprehensive understanding of technical standards for CMC analytical studies on this online course
Course 2/3 of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series - Discover the key regulatory, technical and quality elements
The second course in the online biopharmaceutical and biosimilar CMC analytical series follows on from the first course on regulatory challenges. This course focuses on analytical method lifecycles as well as characterization and control of product reference standards. Learn more about the series here.
This course has been designed to provide you with the technical know-how, so you 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/biosimilar products.
In addition, you will learn about the quality, regulatory and monitoring aspects of different types product reference standards and critical assay reagents.
What will you learn?
Examine analytical QbD and how it differs from traditional strategies.
Define the difference between method verification, qualification and validation, and discover how to overcome common challenges of analytical methods
Examine best practice when methods change and explore the various biotech reference standards
Critical assay reagents
Assess the various critical assay reagents and learn best quality practices when managing a reference standard and critical assay reagent program
Who is this course for?
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.
BIOPHARMACEUTICAL AND BIOSIMILAR CMC ANALYTICAL AND LAB QUALITY SERIES
Purchase a place on all 3 online academies in the series and receive the final place at half price, saving you a total of £440 + VAT. Attending all 3 courses will provide you with a complete understanding of the regulatory, technical and quality requirements for CMC analytical studies.
To take advantage of this offer please get in touch with our training consultants at Jessica.Purnell@informa.com or call +44 (0)20 7551 9521.
Regulatory and Compliance Requirements for CMC Analytical Studies
Discover key regulatory requirements for CMC analytical studies to ensure global compliance
Product Specifications, Stability, Comparability and Similarity for CMC Analytical Studies
Learn best practices for ensuring the quality and efficacy of your products
Find out more about online courses...
BioProcess International Academy online courses 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.