PDA Fundamentals of Aseptic Processing

07 Nov - 08 Nov 2024
Dublin, Ireland

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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):

Agenda

Discover What's Happening Each Day
Day 1 07 Nov Day 2 08 Nov Workshop Training
Thursday, 7 November

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

Friday, 8 November

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

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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

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
By Air The closest airport is Dublin Airport.
By Car The hotel is only a 20-minute car ride away from Dublin Airport.
By Other Options Take the Dublin Express train to get from the airport to the hotel, it takes around 1,15 h.
Travel and Exclusive Discount Information
Special Lufthansa Group Airlines Fares
Special Lufthansa Group Airlines Fares

The Lufthansa Group airlines bring people together – every day, all around the world.The global route network of Austrian Airlines, Lufthansa, SWISS, Brussels Airlines and Eurowings offers optimal connection and combination options, so you will benefit from quick and direct flights to the event.

You will reach the booking platform via this link https://www.lufthansa.com/de/en/meetings-and-events-delegates and with the event code DEAPIBJ. The reduced fares are automatically displayed.

Note: Please enable pop-ups permanently in your browser while booking, otherwise the window in the booking platform will not open.

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.

Book Flight
Special Deutsche Bahn Train Fares
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Get there relaxed – get there sustainable – travel CO2-free. Your Event Ticket at a fixed price throughout Germany. From any Deutsche Bahn station to our event, with the City-Ticket included.

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€

Book online now and get the lowest price for your preferred route – guaranteed. For technical questions, please contact the service number +49 (0) 30 58 60 20 901. Create the perfect start for your sustainable event: Make active use of your journey to work or just relax and enjoy the high-speed travel experience – with 100% renewable power on regional and long-distance services.

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Registration

Pricing Options

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. 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.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

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