PDA Fundamentals of Contamination Control for Aseptic Processing Operations Training Course
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Registration Options
Individual Registration
Group Registration
This training course provides participants with a structured and practice-oriented understanding of aseptic processing and contamination control. It goes beyond theoretical learning by connecting regulatory expectations with day-to-day operational reality in sterile manufacturing.
The program covers the key elements that determine sterility assurance in aseptic operations, including:
- Fundamental of microbiology concepts
- The principles of cleaning and disinfection
- Cleanroom behavior
- Fundamentals of environmental monitoring
- Fundamentals of first air and airflow visualization
- Fundamentals of barrier technology
- Practical aspects of aseptic interventions and equipment setup
A strong focus is placed on Grade A protection for modern aseptic processing environments. The training course is designed to be interactive and engaging, combining expert-led input with discussion-based learning and practical examples. Participants will strengthen their ability to recognize and assess typical contamination risks, and translate best practices into robust procedures for their own aseptic operations.
Who Should Attend
Personnel involved in Aseptic Processing from sterile production departments such as:
- Production Management and Shop Floor Supervisors
- Qualified Persons
- Compliance Experts
- Quality Assurance Managers
- Quality Control Microbiologists/Environmental Monitoring Specialists
- Personnel from technical departments
Learning Objectives
Participants will be able to:
- Evaluate current aseptic processing procedures and identify key contamination risk drivers
- Apply cleanroom behavior and gowning principles to reduce human-factor related contamination risk
- Explain basic microbiology concepts relevant to aseptic processing and contamination control
- Determine essential components of an effective environmental monitoring program and interpret results
- Assess cleaning and disinfection strategies, including practical considerations for glove disinfection
- Understand the fundamentals of Grade A protection, barrier systems, and material transfer principles
- Interpret airflow principles, “First Air” concepts, and smoke study outcomes in the context of aseptic processing
- Examine aseptic fill operations to ensure appropriate interventions, setup, and observations occur
- Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
Highlighted Trainers
Key Presenters
Agenda
Discover What's Happening Each Day
(Note: The file may take a moment to download depending on your connection.)
CEST Daylight Time (UTC +2:00)
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Welcome and Collection of Participants’ Expectations
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Contamination Control Strategy as the Basics for Aseptic Processing
- Introduction and basics of the CCS
- Regulatory requirements and expectations
- Maintaining an effective CCS
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Fundamentals of Microbiology and Aseptic Processing
- Background on key concepts of microbiology
- Regulatory requirements and expectations
- Overview of environmental monitoring programs (air, surfaces, personnel)
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Coffee Break
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Fundamentals of Cleaning and Disinfection
- Key elements for cleaning & disinfection in cleanrooms
- Regulatory requirements and expectations
- Hazard scenarios in cleaning and disinfections
- Practical Part: Disinfection with UV & GMP-conforming cleaning
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Lunch Break
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Glove Disinfection and Disinfection Agents
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Coffee Break
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Considerations & Pitfalls in
- Cleaning and Disinfection
- Environmental Monitoring
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Fundamentals of Gowning in Cleanrooms and Personnel Transfer
- Key elements for gowning in different cleanroom grades
- Demonstration of risks and possible errors during gowning
- Practical Part: Correct Gowning
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Cleanroom Controls, Operations and Behavior
- Background on key concepts on cleanroom controls
- Introduction to correct cleanroom behavior
- Regulatory requirements and framework
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Attendee Questionnaire Day 1 & Round Table Discussions with participants
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End of Training Course Day 1
CEST Daylight Time (UTC +2:00)
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Introduction to Barrier Systems (Isolators, RABS) and Material Transfer
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Recap of Day 1
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Fundamentals of First Air and Smoke Studies
- Key elements of first air and how it protects critical process areas
- Rules for maintaining first air integrity
- Practical Part
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Coffee Break
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Fundamentals of Aseptic Processing
- Background on different cleanroom technologies (RABS; isolator, closed systems/robotics)
- Principles of equipment setup
- Regulatory requirements and expectations
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Risks during Aseptic Interventions and Equipment Setup: Theoretical Part I
- Risks and errors during material transfer and equipment setup
- Background on common aseptic interventions
- Regulatory requirements and expectations
- Risks and errors during aseptic interventions
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Lunch Break
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Continued Risks during Aseptic Interventions and Equipment Setup: Theoretical Part II and Practical Part
- Risks and errors during material transfer and equipment setup
- Background on common aseptic interventions
- Regulatory requirements and expectations
- Risks and errors during aseptic interventions
- Practical part
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Coffee Break
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Round Table Discussion
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Wrap up, Q&A & Attendee Questionnaire
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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.
PDA recommends the reservation at the following hotel
Hotel am Borsigturm
Am Borsigturm 1
13507 Berlin, Germany
The hotel is located a five-minute walk from the training course venue.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€ 2,200Non-Member
€ 2,350
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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