Summary
This 3-day online training is a deep dive into the world of state-of-the-art process scale-up and technology transfer of biologics. You will obtain crucial tools for designing quality into processes and managing the complex regulatory landscape.
Learning Objectives
- Understand the regulatory landscape for process validation & technology transfer
- Apply QbD principles to scale-up, validation & technology transfer of biologics
- Learn from proven best practices for scale-up of biologics manufacturing processes
- How to work with and manage suppliers
- Theory vs. practice and overcoming regulatory challenges
Key Topics
- Scale-up of bioprocesses
- QbD principles during process development & scale-up
- Process validation & managing regulatory changes
- Process risk assessment
- Continued process verification
- Process performance qualification
- Technology transfer – regulatory, planning & execution
Who should attend?
- Pharmaceutical Technologists
- Bioprocess Scale up Scientists
- Bioprocess Engineers
- Process Scientists and Process Engineers
- Process Validation Specialists
- Technology Transfer Specialists
- Manufacturing Management
- Regulatory Affairs Managers
- Quality Assurance Managers
- Manufacturing Project Management
- CMO Managers
Past Participants
- Senior Scientist, CGTT, Orchard Therapeutics
- USP Manufacturing Technician, Alvotech
- Head of Production, F. Hoffmann-la Roche
- Technical Project Leader, Fujifilm
- R&D Scientist, ProBioGen
- DSP Process Transfer Lead, UCB
- Director, Quality Assurance, Adverum Biotechnologies
- Project Manager Validation Services, Sartorius
- Senior Process Scientist, Bluerock Therapeutics
- R&D Manager, MilliporeSigma
- Process Engineer, Morphosys
- Scientist Process Development, Novozymes
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017, he founded BioFrey and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.
Process Scale-up, Validation and Technology Transfer for Biologics
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