Summary
This three-day training course is intended to provide insight into how state-of-the-art Process Scale-up, Technology Transfer, and modern Process Validation are tied together by applying Quality by Design principles. The regulatory requirements will be explained, and case studies will help you understand how to translate theory into practice and overcome frequently faced challenges.
Learning Objectives
- Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles
- Gain regulatory insights & guidance on how to realize Technology Transfers and PV
- Explore proven best practices in Scale-up for solid dose manufacturing processes
- Gain practical knowledge and tools during two interactive sessions and workshops
- Take an excellent opportunity to discuss issues & challenges with industry peers and with an expert
Key Topics
- QbD Principles during Process Development and Scale-Up
- Scale-Up of Granulation and Tableting Process
- Technology Transfer: Regulatory, Planning & Execution
- Process Validation new guidance and requirements
- Process Design Stage: Key input for Product and Process Quality
- Process Performance Qualification
- Continued Process Verification
- Process risk assessment
Who should attend?
Pharmaceutical Technologists, Process Scientists and Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, Quality Assurance Managers, Manufacturing Project Management
Past participants
- Manager Technology Transfer, Stada Arzneimittel
- Research and Development Manager, Unipharm
- Snr Technical Manager, Oriflame
- Formulation Development Associate, Idorsia
- Process Validation, Manufacturing, Packaging, Coripharma
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 30 days
- Digital and LinkedIn certificates
Trainers
Process Scale-up, Validation & Technology Transfer
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
