Basics in Biopharmaceutical Manufacturing

Short description

What can you  expect from this training course?

The following topics will be covered during this training course:

Interactive theory:

• Introduction to GMP
• Equipment Qualification
• Basic Principles in Biopharmaceutical manufacturing (different steps in Upstream and Downstream processing)
• Drug Product manufacturing and aseptic filling
• Testing, review and release

Practice yourself:

• Tube welding
• Aseptic Handling
• Gowning up until class B

Demonstration:

• Aseptic Filling Line​
• HVAC & WFI production (Water for injection)

Objectives

After the training course you will be able to explain:

• Background and the why of GMP

• Common production steps in biopharmaceutical GMP manufacturing
• What is required to control the quality of air in a cleanroom
• How it is to work under GMP in a cleanroom
• What is required for aseptic manufacturing
• What is required to release a drug product 

Target group

This training course is suitable for

• consultants
• technical staff
• engineers
• managers 
• anyone who wants to learn the basics of Biopharmaceutical GMP Manufacturing

No particular prior knowledge is required to participate in this training.