Entry Level Process Validation for Biotechnological Products - US edition MasterClass

This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product.

11-14 September, 2023, Virtual

Time Zone: Eastern Daylight Time (EDT) - UTC−04:00

Overview

This masterclass will introduce participants to QbD concept, process validation and regulatory requirements, and will provide as well keys to successfully drive your product to market authorization.

This course will cover the definition of QbD concept and process validation, describing all key studies and scientific requirements for developing your biotechnological product. It will describe FDA and European guidelines, including the review of the IND and CTD documents, in term of regulatory expectations, to guide you to the market registration of your product.

#masterclass     #glceurope      #pharmaonlinetraining      #globalleadingconferences       #processvalidation      #entrylevelprocessvalidation        #biotechnologicalproducts

RECOMMENDATION

Who should attend?

• Process development scientists and managers
• CMC development program managers
• Pharmaceutical development scientists and managers
• Manufacturing managers
• QC and stability control managers
• Heads of Quality Assurance
• Drug Regulatory Affairs managers