PDA Fundamentals of Aseptic Processing

Berlin, Germany
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Please note that this training course has hands-on activities. Please wear long pants and closed-toe shoes.

Innerspace PDA Partnership

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):

Standard Registration

Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

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

Tuesday, 30 July 2024

9:00
Welcome and Introduction, collecting Participant’s Expectations

9:30
Fundamentals of Cleaning and Disinfection

  • Key elements for cleaning & disinfection in cleanrooms
  • Regulatory requirements and expectations
  • Hazard scenarios in cleaning and disinfection
  • VR Simulator Session (hands-on): Avoiding risks during disinfection procedures

  • 11:15
    Coffee Break

    11:30
    Fundamentals of Gowning in Cleanrooms

    • Key elements for gowning in different cleanroom grades
    • Demonstration of risks and possible errors during gowning

    12:30
    Lunch Break

    13:30
    Fundamentals of Microbiology and Environmental Monitoring

    • Background on key concepts of microbiology
    • Regulatory requirements and expectations
    • Overview of environmental monitoring programs (air, surfaces, personnel)
    • VR Simulator Session (hands-on): Avoiding risks in environmental monitoring

    15:15
    Coffee Break

    15:30
    Cleanroom Controls, Operations, and Behavior

  • Background on key concepts of cleanroom controls
  • Introduction to correct cleanroom behavior
  • Regulatory requirements and framework
  • VR Simulator Session (hands-on): Train how to move correctly in cleanrooms

  • 17:00
    Q&A

    17:30
    End of Training Course Day 1

    Day 2

    Wednesday, 31 July 2024

    9:00
    Wrap-Up Day 1 and Q&A

    9:30
    Fundamentals of First Air

  • Key elements first air and how it protects critical surfaces
  • VR Simulator Session (hands-on): Understanding how to interact with the first air

  • 10:45
    Coffee Break

    11:00
    Fundamentals of Aseptic Processing, Material Transfer, and Equipment Setup

  • Background on different cleanroom technologies (RABS; isolator, closed systems/robotics)
  • Principles of material transfer and equipment setup
  • Regulatory requirements and expectations
  • Most common hazard scenarios and errors during material transfer and equipment setup

  • 12:30
    Lunch Break

    13:30
    Fundamentals of Aseptic Interventions

  • Background on common aseptic interventions
  • Regulatory requirements and expectations
  • Most common hazard scenarios and errors during aseptic interventions
  • VR Simulator Session (hands-on): Avoiding risks in aseptic interventions

  • 15:15
    Coffee Break

    15:30
    How to Design Effective Training and Oversight

  • Background on knowledge management and training
  • Guidelines on how to design great training materials
  • Background on effective QA oversight
  • Regulatory requirements and framework

  • 17:00
    Q&A

    17:30
    End of Training Course

    Agenda is subject to change.

    Featured Trainers

    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 five minutes walk from the training course venue.

    How to Get Here
    By Air Closest airport is the Berlin/Brandenburg Airport BER with 60 minutes away by taxi.
    By Other Options By train: Around 40 minutes with public transportation away from the Berlin main station.
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    Event Ticket one-way and specific train (subject to availability):

    • 1st class 89,90€ (seat reservation incl.)
    • 2nd class 55,90€

    Event Ticket one-way and fully flexible:

    • 1st class 112,90€ (seat reservation incl.)
    • 2nd class 77,90€

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