Process Scale-up, Validation and Technology Transfer for Biologics
WHY SHOULD YOU ATTEND?
Master Regulatory and Validation Requirements
Gain a clear understanding of global regulatory expectations for process validation and technology transfer, ensuring compliance and smoother approvals.
Apply QbD for Robust Scale-Up
Learn how to integrate Quality by Design principles into process development to achieve consistent, high-quality biologics production.
Overcome Real-World Scale-Up Challenges
Explore proven best practices, risk assessment tools, and strategies to navigate technical and regulatory hurdles during scale-up.
Streamline Technology Transfer
Acquire practical frameworks for planning, executing, and managing supplier relationships during complex technology transfers.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Build Quality into Biologics Processes
Learn how to design manufacturing processes where quality is embedded from development through commercial production
Apply QbD Principles Effectively
Use Quality by Design to guide scale-up, validation, and technology transfer for consistent, high-quality outcomes
Navigate Regulatory and Change Management
Understand global regulatory requirements and apply strategies to manage process changes without delays
Ensure Smooth Technology Transfers
Work seamlessly with suppliers and partners to plan, execute, and troubleshoot technology transfer projects
WHO IS THIS TRAINING FOR?
Process Engineers and Scientists
MSAT
USP/DSP
Process Validation
KEY TOPICS
Scale-up of bioprocesses
QbD principles during process development & scale-up
Process validation & managing regulatory changes
Process risk assessment & Continued process verification
Technology transfer – regulatory, planning & execution
TRAINER
PAST PARTICIPANTS
Process Scale-up, Validation and Technology Transfer for Biologics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
