ENTRY LEVEL
In-House Training
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.
Understand the purpose of process validation and its 3 stages
Learn regulatory guidelines related to process validation activities for drug substance and drug product
Understand how to set-up a control strategy
Examine how to assess microbiological risks (including viruses) during manufacturing
Discover studies that need to be performed prior to BLA
Learn keys to drive a process validation project to success
Process development scientists and managers
CMC development program managers
Pharmaceutical development scientists
Pharmaceutical development managers
Manufacturing managers
QC and stability control managers
Heads of Quality Assurance
Drug Regulatory Affairs managers
Introduction
Purpose of process validation
QbD concept and design space as new paradigm
Regulatory Considerations
Common Technical Document (CTD)
Regulatory guidelines
Overview of Process Validation
Documentation and studies for the BLA
Stage 1: Process Design
Stage 2: Process Performance Qualifaction
Stage 3: Continued Process Verification
Cell bank system qualification
Viral clearance
Safety aspects
Case studies
How to drive a process validation project to success
Questions and answers
Please contact us at mylene.talabardon@biotechnologyconsultant.com