PDA Fundamentals of Aseptic Processing
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Individual Registration
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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. [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.
Day 1
Thursday, 07 November 2024
9:00
Welcome and Introduction, Collecting Participant’s Expectations
9:15
Fundamentals of Microbiology and Aseptic Processing
9:40
Glove Disinfection and Disinfection Agents
10:00
Group Exercise – Disinfection Procedure
10:30
Coffee Break
10:45
Key Hazards in Cleaning and Disinfection
11:30
Virtual Reality Simulator: Correct Disinfection Procedure
12:30
Lunch Break
13:30
Fundamentals of Gowning and Personnel Transfer
14:00
Introduction to Barrier Systems (Isolator, RABS) and Material Transfer
14:30
Coffee Break
14:45
Fundamentals of Environmental Monitoring
15:15
Virtual Reality Simulator: Personnel Monitoring, Air Monitoring, Surface Monitoring
16:00
Key Hazards in Environmental Monitoring
16:30
Q&A
17:00
End of Training Course Day 1
Day 2
Friday, 08 November 2024
9:00
Recap Day 1
9:15
Fundamentals of First Air and Smoke Studies
9:45
Virtual Reality Simulator: First Air
10:45
Coffee Break
11:00
Fundamentals and Key Hazards of Equipment Setup
11:30
Fundamentals and Key Hazards of Aseptic Interventions
12:00
Lunch Break
13:00
Virtual Reality Simulator: Aseptic Interventions
14:00
Key Insights to Design Knowledge Management, Training and Oversight
14:45
Coffee Break
15:00
Wrap up & Q&A
15:45
End of Training Course
Featured Trainers
-
Hussein Bachir, Dr. rer.nat
Scientist - GMP Compliance, Franz Ziel GmbH
Read Bio
Hussein Bachir, Dr. rer.nat
Franz Ziel GmbH
Dr. Hussein Bachir is part of the GMP Compliance Team at Franz Ziel GmbH and has nine years of laboratory background in the field of scientific research and translational medicine. As a scientist in GMP compliance, he focusses on GMP compliant process integration and presenting scientific GMP topics from Franz Ziel on international conferences. Hussein received his PhD in Biology working on treatments for rare kidney diseases at the University Hospital of Muenster/University of Muenster. He continues to strive for better life conditions and protecting life with technology by combining his passion for scientific research and technology at Franz Ziel. -
Tarik Cheema, PhD
End to End Contamination Control Manager, F. Hoffmann-La Roche AG
-
Sebastian Scheler, MSc
Managing Director and Chief Methodologist, Innerspace GmbH
Read Bio
Sebastian Scheler, MSc
Innerspace GmbH
Co-Founder Innerspace | Managing Director | Chief Methodologist | Frame-by-Frame Risk Profiling Supervisor I am dedicated to advancing risk assessment technologies, aiming to improve the design and management of manufacturing processes in the pharmaceutical industry. As the leader of a dynamic team comprising life science professionals and software developers, I focus on innovative AI-solutions that drive efficiency, compliance, and safety. My professional expertise centers on Frame-by-Frame Risk Profiling—an automated approach to risk assessment that enhances process improvement, automation, autogenerated SOPs, and immersive training programs. This cutting-edge technology empowers organizations to achieve unprecedented levels of operational excellence. With a strong foundation in psychology, I am deeply interested in the intersection of human behavior and technology. My passion for Virtual Reality (VR) has led to the development of pioneering VR simulator methodologies that advance experiential learning, training, and behavior measurement systems. In addition to my leadership role at Innerspace, I also serve as a trainer for PDA training courses and contribute to the ongoing development of the PDA/Innerspace partnership. This collaboration focuses on refining the delivery and design of training courses to meet the evolving needs of the industry.
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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.
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