Process Scale-up, Validation & Technology Transfer

Summary

This three-day training course is intended to provide insight 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 on how to translate theory into practice and overcome frequently faced challenges.

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

Learning Objectives

• Understand industry approaches for Scale-up, Technology Transfer and PV applying QbD principles
• Gain regulatory insights & guidance 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

Programme

• Training materials will be provided in digital form
• All delegates will receive digital certificates of attendance and LinkedIn certificates