PDA Single-Use-Systems – A New Age of Drug Making Training Course
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Individual Registration
Group Registration
In the biomanufacturing world, a huge product diversification occurs place with new therapeutic approaches rising. Novartis e.g., recently released a new gene therapy drug for two Million Euros per dose, while other companies are still in the development phase for drugs targeting the same disease. Wouldn’t it be great for them to have released these drugs faster to be the first one and to make two Million Euros per dose themselves? And what technologies might have helped to reach this goal?
One possibility to get drugs faster to the market is the use of single-use systems. But are they robust enough when the product contact layer is made from polymers? And what will the authorities say? If want to learn more about that topic, then you should sign up for this two-day course. Here you will learn and discuss with technical trainers and specialists for data handling and GMP regulations how to implement and operate single-use technologies in a GMP-controlled environment.
During an optional third day, you can look into the manufacturing of single-use bioreactor bags and filters, followed by a visit to the Sartorius Application Centre where you can see and test complete process solutions from molecule discovery to large-scale biomanufacturing.
Who Should Attend
- Operators
- Manufacturing Supervisors
- QA Managers
- Manufacturing Managers
- QC Managers
- Auditors
Learning Objectives
Upon completion of this course, attendees will be able to:
- Have understood the regulations and relevant guidelines for single-use system (SUS) handling
- Can explain basics in single-use processing, bag functionalities, connection-disconnection technologies
- Can operate bags, tubings, filters, and sensors
- Have understood Data Integrity and Data Analysis / Monitoring for SUS handling
- Have understood possible setups for filter and container closure integrity testing in single-use assemblies
Program Highlights
Using single-use systems in GMP regulated biomanufacturing – a practical approach
This course will take place at the Sartorius Stedim facilities in Göttingen.
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
Tuesday, 03 June 2025 - Optional Facility Tour
13:00 - 14:00
Lunch
14:00
Campus and Application Center Tour
17:30
End of Facility Tour
19:00
Joint Dinner
Wednesday, 04 June 2025
8:30
Welcome & Introduction of Participants; Safety Briefing
9:00
Introduction to Single-Use Bioprocessing
9:45
GMP Update on Single-Use-Systems (Part 1)
- Current GMP Regulation
- FDA Requirements
- Technical Guidelines
- Regulatory Expectations
10:30
Coffee Break
10:45
GMP Update on Single-Use-Systems (Part 2)
- EU GMP Annex 1
11:15
Hands-on Exercise 1
- Gowning
- Experiment with the Advantages of Single-Use-Systems
12:15
Lunch Break
13:15
Basics in Single-Use Bioprocessing Focus on Bags
- Manufacturing of Single-Use Consumables
- Different Bag Functionalities
14:15
Coffee Break
14:30
Hands-on Exercise 2 (Cleanroom)
- Connection/Disconnection
16:30
Wrap-up Day 1
17:00
OPTIONAL: Virtual Reality Demo: Operator Training
- BioWelder or Mixing Demo
18:00
End of Training Course Day 1
19:00
Joint Dinner
Thursday, 05 June 2025
8:30
Sensors and Automation in Single-Use Systems
- Overview and Demonstration
9:15
Hands-on of Exercise 3
- Overview Bag Types
10:15
Coffee Break
10:30
Data Integrity, Data Analysis and Monitoring
- Regulatory Requirements and Guidelines
- ALCOA
- Data Integrity for Computer, Paper, and Hybrid Systems
- Control of Meta-Data
- Data Integrity Strategies for Compliance
- Checking for Data Integrity Issues in Practice
- Experimental Approach
11:30
Data Recording & Evaluation
- Data Logging
- Batch Monitoring
12:00
Lunch Break
13:00
Filtration & Container Closure Testing Hands-on Exercise 4 (Cleanroom)
- Filter Integrity Testing in Single-Use-Systems
- Bag Assembly Integrity Testing
- Transferset for Final Filling & PUPSIT
14:30
Coffee Break
14:45
Filter Integrity Testing Fault Handling – GMP View
- GMP Requirements
- Pre- and Post-Use Integrity Testing
- Impact of EU GMP Annex 1 Requirements
15:15
GMP Practical Session
- Failed Filter in Integrity Testing - What to do under GMP?
- What are the Differences between Media Preparation and Final Filtration of a Drug Product Prior Filling?
- 'Bioburden Reduction' vs. 'Sterile Filtration'
16:00
Wrap-up Day 2
16:30
End of Training Course
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Sartorius Stedim Biotech
Otto-Brenner Str. 20Göttingen, Germany 37079 Germany
Reservation Instructions
PDA Europe recommends to reserve a hotel room close to the trainings location.
Best Western Hotel Am Papenberg
Hermann-Rein-Straße 2
37075 Göttingen
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€2,200Non-Member
€2,200
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
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