PDA Extractables and Leachables Training Course Fall Edition
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
When making parenteral drug products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues (i.e. for biopharmaceuticals) have also become a concern.
This training course will look at Extractables & Leachables from many different angles, including, Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, and Study Design for different parenteral primary packaging systems and injection devices.
A full session will be dedicated to an in-depth update on regulations, standards, and recommendations in this field (PQRI, USP, ISO 10993, BPOG).
Who Should Attend
- Pharmaceutical Packaging and Device Engineers
- Production Engineers, using SU systems
- Regulatory Affairs Officers
- Pharmaceutical R & D Managers
- Analytical Chemists, working on E/L
- Quality Assurance Officers
Learning Objectives
Upon completion of this training course, you will be able to:
- Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
- Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
- Understand the materials of construction, including composition, of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
- Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
- Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study
Program Highlights
This training course will look at Extractables and Leachables from many different angles: definitions, regulations, material and polymer science, analytical E/L methodologies, safety assessments, and study design for different parenteral primary packaging systems and injection devices.
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
Thursday, 23 October 2025
08:45
Welcome and Setting the Stage
09:15
Introduction & Regulatory Aspects
10:15
Polymers 101
10:30
Networking Coffee Break
10:45
Polymers 101
12:00
Networking Lunch Break
13:00
How to Set-Up & Do’s/Don’ts in Extractables Studies
14:45
The AET: Cornerstone of the Qualification
15:00
Networking Coffee Break
15:15
How to Set-Up & Do’s/Don’ts in Leachables Studies
16:00
New & Upcoming Regulatory Documents & Impact
16:30
Toxicology 101
17:00
End of Training Course Day 1
Friday, 24 October 2025
08:45
Analytical Approaches in E/L
09:15
E/L and SVP Applications
10:15
Networking Coffee Break
10:30
Disposable and SUS
11:45
LVP & Simulation Studies
12:30
Networking Lunch Break
13:30
Special Case: Biologics
14:00
USP Update
14:45
Networking Coffee Break
15:00
Combination Devices
16:00
End of Training Course
Location and Travel
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.
Venue: Austria Center Vienna
Bruno-Kreisky-Platz 1Vienna, Austria 1220
Reservation Instructions
The Austria Center Vienna is a premier venue for conferences and exhibitions, located in the heart of Vienna, Austria. Known for its state-of-the-art facilities and exceptional connectivity, the center offers an ideal setting for global events. With its modern infrastructure, spacious exhibition halls, and a reputation for hosting international gatherings, it provides attendees and exhibitors with a seamless and professional environment to network, exchange knowledge, and showcase innovations.
Welcome to Your Preferred Hotel Booking for the PDA Extractables and Leachables Training Course Fall Edition
PDA Europe and our partner optiMICE secured the best rates at hotels conveniently located near the Austria Center Vienna, ensuring a comfortable and seamless stay.
As a training course attendee, you can enjoy exclusive hotel rates tailored specifically for this event. With our close partnerships, we offer competitive prices and prime accommodations to make your time in Vienna stress-free and enjoyable.
For any questions about your stay or booking assistance, please feel free to reach out to optiMice anytime to make your Vienna visit smooth and memorable.
Hotels Nearby
Click the link below to view the list of available hotels. The distance in kilometers next to each hotel name indicates how far it is from the Austria Center Vienna, the conference venue. For individual reservations less than five rooms please use the link below.
For Group Bookings for more than 5 rooms, please contact optiMice here:
optiMICE - Hotels for Events
email: [email protected]
phone: +49 2243 923 9008
Please note: All hotel bookings will be managed through PDA's official hotel partner, optiMICE – Hotel for Events. For any questions or assistance, please contact optiMICE directly. Additional details can be found at the link above.
How to Get Here
Area Attractions
- Explore the City’s Historical Sites: Visit Schönbrunn Palace, St. Stephen’s Cathedral, and the Vienna State Opera.
- Enjoy World-Class Museums: Explore the Albertina Museum or the Natural History Museum.
- Relax at the Danube River: Take a stroll or enjoy a river cruise close to the conference venue.
- Sample Viennese Cuisine: Try Wiener Schnitzel, Sachertorte, or a coffee in a traditional Viennese café.
Did you know? Vienna is renowned for its exceptionally pure drinking water, sourced directly from alpine springs. The water quality is so high that it is considered among the best in the world and even powers small hydroelectric plants on its way to the city.
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. [email protected]
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 [email protected] 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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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