Process Scale-up, Validation and Technology Transfer for Biologics (US Edition)
Process Scale-up, Validation and Technology Transfer for Biologics (US Edition)

Course Description

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.
  • 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
  • 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

Process Scale-up, Validation and Technology Transfer for Biologics

19 - 21 March 2024, Live Online Training
€1.850,00
Dr. Sam Denby

Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and BD. In 2017, he founded BioFrey and has revolutionised availability of extractable data and change notification practices around single use systems, facilitating the uptake of these systems.

START TIMES

3:00 PM Vienna time

2:00 PM London time

10:00 AM New York time

7:00 AM Los Angeles time

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Course Description

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.
  • 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
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

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.

Medical-Devices-Certificate-Course

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