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Process Scale-up, Validation & Technology Transfer
Scale up
Pharma & Biotech
CMC

Process Scale-up, Validation & Technology Transfer

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles

Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles

Learning Objective

Gain regulatory insights & guidance on how to realize Technology Transfers and PV

Gain regulatory insights & guidance on how to realize Technology Transfers and PV

Learning Objective

Explore proven best practices in Scale-up for solid dose manufacturing processes

Explore proven best practices in Scale-up for solid dose manufacturing processes

Learning Objective

Gain practical knowledge and tools during two interactive sessions and workshops

Gain practical knowledge and tools during two interactive sessions and workshops

Learning Objective

Take an excellent opportunity to discuss issues & challenges with industry peers and with an expert

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

TRAINER

Dr. Michael Braun

Dr. Michael Braun

Boehringer Ingelheim Pharma, Director Late Stage Drug Product Development

Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in the pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma. In 2006, Michael joined Boehringer Ingelheim and worked in different positions with increasing responsibility within Pharmaceutical Development and R&D Project Management. Since 2014, he is Director Late Stage Drug Product Development and responsible for process development and scale-up of solid and liquid orals, parenterals and inhalative NCE products. This also includes product transfers to operations, launch support and preparation of submission documentation.

Learn More →

Sneak peek

Sneak Peek

Take a sneak peek at the trainer's presentation.

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