Summary
This training course provides vital practical insights into QbD-implemented Process Scale-up, Technology Transfer and Process Validation for sterile injectable dosage forms. Scale-up and tech transfer are a key step to be completed before being able to submit and eventually commercialize any pharmaceutical product. Tech transfer can happen internally, or externally, to a CMO. Both scenarios come with their own peculiar challenges. During the course, we will dig into tech transfer. How can we map the road to a seamless process? What are the do’s and don’ts? We will be sharing specific examples of aseptic injectables and discuss the challenges and requirements of this dosage form.
Learning Objectives
- Understand industry approaches for Scale-up, Tech Transfer and PV applying QbD principles
- Explore proven best practice in Scale-up and Tech transfer for sterile injectables
- Take an excellent opportunity to discuss issues and challenges with industry peers
- Gain practical knowledge from case studies
Key Topics
- QbD Principles During Process Development and Scale-Up
- Process Scale-Up of Sterile Injectable Dosage Forms
- Technology Transfer: Regulatory, Planning & Execution
- Process Validation New Guidance and Requirements
- Aseptic Processing
- Media Fills
- Process Risk Assessment
- The Future of Aseptic Manufacturing
Who should attend?
Injectables Technologists, Process Scientists, Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, QC & QA Managers
Past participants
- Drug Product Subject Matter Expert, Pfizer
- CMC Project Manager, Britannia Pharmaceuticals
- Formulation Development Coordinator, Boehringer Ingelheim
- Project Coordinator, Ferring Pharmaceuticals
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
- Digital and LinkedIn certificates
Trainers
Process Scale-up & Tech Transfer for Injectables
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
