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Quality Requirements for Biologics
CMC
Pharma & Biotech

Quality Requirements for Biologics

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING LOCATION

Vienna, Austria
-
In-Person Training



LEARNING OBJECTIVES

Learning Objective

Understand the regulatory landscape

Understand the regulatory landscape

Learning Objective

Overview over GMP and quality requirements for the manufacture

Overview over GMP and quality requirements for the manufacture

Learning Objective

Learn about the development and the requirements for manufacturing

Learn about the development and the requirements for manufacturing

Learning Objective

Modern process validation concepts and biologics

Modern process validation concepts and biologics

Learning Objective

How to implement effective process changes

How to implement effective process changes

Learning Objective

Implementation of analytical methods for biologics and requirements

Implementation of analytical methods for biologics and requirements

Learning Objective

Release specification compared to in-process control requirements

Release specification compared to in-process control requirements



KEY TOPICS

Regulatory framework
Quality & GMP requirements
Manufacturing of the drug substance & IMPs
Process validation
Managing process changes
Analytical methods
Release specification vs IPC requirements