PDA Fundamentals of Aseptic Processing
Registration Options
Individual Registration
Group Registration
Please note that this training course has hands-on activities. Please wear long pants and closed-toe shoes.
The training course aims to provide participants with a deeper understanding of the fundamentals of aseptic processing by going beyond traditional learning materials.
Through data-driven presentations, interactive discussions, and real-world problem-solving in Virtual Reality, attendees will gain insights into guidelines, Warning Letters, and practical solutions for everyday job challenges. The course will cover a variety of hot topics including best practices and aseptic techniques, cleaning and disinfection, gowning, microbiology, training, and motivation of staff.
The program emphasizes a risk-based approach, utilizing Frame-by-Frame Risk Profiling technology to analyze frequent and critical hazard scenarios within each topic area. This method provides participants with a comprehensive understanding of potential risks and equips them with mitigation strategies to reduce these risks effectively.
The training course promises a lively and engaging learning experience for all attendees, blending theoretical knowledge with practical skills through interactive sessions and innovative technology. By utilizing the Virtual Reality Cleanroom Simulator to illustrate key cleanroom principles and common misbehaviors, participants will be better equipped to excel in their roles and uphold high standards in aseptic processing. They can immerse themselves in a realistic cleanroom environment to practice aseptic techniques, deepening their knowledge and skills. This hands-on experience also helps them identify and prevent potential human errors and associated risks in aseptic production.
Who Should Attend
Personnel involved in Aseptic Processing from sterile production departments such as:
- Production Management and Shop Floor Supervisors
- Qualified Persons
- QA and QC Microbiologists
- Personnel from technical departments
Learning Objectives
- Evaluate current aseptic processing procedures
- Assess potential risks of product contamination using airflow visualization techniques
- Determine the necessary components of an effective environmental monitoring program
- Examine cleanroom fill operations to ensure appropriate interventions and observations occur
- Review basic microbiology concepts and techniques for multiple aspects of aseptic processing
- Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
- Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
- Understand potential hazard scenarios within different fields of aseptic procession
- Raise awareness of individual human errors through simulator feedback
- Gain authentic cleanroom experience by exploring immersive Simulator modules in VR
For more options and/or related training courses, please visit the following page(s):
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Standard Registration
Member Price
€ 2.090Non-Member
€ 2.090
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.
Day 1
Thursday, 07 November 2024
9:00
Welcome and Introduction, collecting Participant’s Expectations
9:30
Fundamentals of Cleaning and Disinfection
11:15
Coffee Break
11:30
Fundamentals of Gowning in Cleanrooms
12:30
Lunch Break
13:30
Fundamentals of Microbiology and Environmental Monitoring
15:15
Coffee Break
15:30
Cleanroom Controls, Operations, and Behavior
17:00
Q&A
17:30
End of Training Course Day 1
Day 2
Friday, 08 November 2024
9:00
Wrap-Up Day 1 and Q&A
9:30
Fundamentals of First Air
10:45
Coffee Break
11:00
Fundamentals of Aseptic Processing, Material Transfer, and Equipment Setup
12:30
Lunch Break
13:30
Fundamentals of Aseptic Interventions
15:15
Coffee Break
15:30
How to Design Effective Training and Oversight
17:00
Q&A
17:30
End of Training Course
Featured Trainers
-
Sebastian Scheler, Mr.
Managing Director, Innerspace GmbH
Read BioSebastian Scheler, Mr.
Innerspace GmbH
I am passionate about pushing the boundaries of advanced risk assessment technologies to unlock new possibilities for designing and managing manufacturing processes in pharma. I spearhead a dynamic team of life science professionals and software developers. The core focus of my professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, I have always been captivated by the intersection of human behavior and technology. My passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems. Beyond my leadership at Innerspace, I also serve as trainer for PDA training courses and further development of the PDA/Innerspace official partnership focusing on refining training course delivery and design.
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Request InformationPLEASE 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.
PDA recommends the reservation at the following hotel
Crowne Plaza Dublin - Blanchardstown
Blanchardstown Town Centre
Dublin, D15 T1FD
Ireland
PDA Europe has reserved a limited number of rooms until 16 September 2024.
Book your room at the PDA Group Rate via the above-mentioned reservation button.
How to Get Here
Travel and Exclusive Discount Information
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Of course, you can also book through your IATA travel agency. The travel agency can request the ticketing instructions by sending an email to lufthansa.mobility@dlh.de, stating the event code DEAPIBJ.
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Event Ticket one-way and specific train (subject to availability):
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- 2nd class 55,90€
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