PDA EU00179 Best Practices and Points to Consider in Aseptic Processing

Seville, Spain
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Program Highlights

Throughout the course, participants will be enabled to use the Virtual Reality (VR) Simulator to gain authentic experiences in aseptic processing. Using VR goggles, participants can immerse themselves in various key moments of aseptic processing and train behavior that is critical to success. During the training in VR, they will receive immediate feedback on possible human errors and learn about risk areas in the cleanroom. Even otherwise invisible phenomena, such as microbiological organisms or air flows (e.g., first air) in the cleanroom, can be simulated and experienced directly. The VR simulator allows participants to link the theoretical content of the course with practical experience, thus supporting the sustainability of their learning effect.

Note PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required.

The aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment and go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring, and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments, and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all. The training course uses also the "Cleanroom Simulator", where participants can have an authentic cleanroom experience in Virtual Reality and gain a better feel for correct aseptic techniques. Each participant can try out different topics in the VR Simulator and in this way deepen their knowledge and skills. In addition, the course uses the VR simulator to illustrate key cleanroom principles (e.g., First Air or Microbiological Contamination) and to demonstrate frequently observed misbehavior for learning purposes. Focus area of the VR-Simulator is to enhance the awareness of potential human errors and their associated risk within aseptic production. Accordingly, all simulator sessions are associated with lectures and/or exercises on potential human error in the area of interest in the course.

  • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
  • Understand key requirements and challenges in parenteral production
  • Understand the importance of a good quality culture within a company
  • Apply the executed and presented case studies and team exercises in her/his daily job
  • Get answers and interpretations about potentially unresolved questions and problems
  • Gain confidence for audits
  • Understand potential human errors within different fields of aseptic procession
  • Raise awareness on individual human errors through simulator feedback
  • Gain authentic cleanroom experience by exploring immersive Simulator modules in VR

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


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, 14 September 2023

09:00 Welcome and Collection of Participant's Expectations

09:30 Team Exercise 1: Discussion of Selected Hot Topics in Aseptic Processing

10:15 Coffee Break

10:45 Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

  • Steam & Dry Heat Sterilization
  • Key Elements for Cleaning & Disinfection in Cleanrooms
  • Gowning Steps for Entering Grade A/B Area
VR Simulator - Session
  • Introduction to VR Simulator and Human Error Analysis

12:30 Lunch Break

13:30 Aspects of Clean Room Concepts and Good Aseptic Working Practices - Part I

  • Conventional Filling Lines
  • RABS Systems and Pharmaceutical Isolators
  • Understanding First Air and Barrier Concepts Including Live-Demonstration/Training of First Air Simulator Module
  • Points to Consider for Aseptic Processing
VR Simulator - Session: Understanding Human Errors and Gaining Hands-On Experience

14:45 Team Exercise 2: How to Build- Up and Maintain an Aseptic Manufacturing Facility

15:45 Coffee Break

16:00 Aspects of Clean Room Concepts and Good Aseptic Working Practices - Part II

  • Smoke Study Learnings
  • Good Aseptic Working Practices Including Live Demonstration/Training of Correct Cleanroom Behavior
  • Examples, Demonstrations and Videos
VR Simulator - Session: Understanding Human Errors and Gaining Hands-On Experience

17:15 Q&A

17:30 End of Training Course Day 1

Day 2

Friday, 15 September 2023

9:00 Best Practices in Aseptic Processing Simulation

  • Basic Concepts and Regulatory Framework about Process Simulations
  • Best Practices in Media Fills for Finished Dosage Form and API
    – TR 22 Process Simulation for Aseptically Filled Products (Under Revision)
    – TR 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals (PDA Survey Results)
  • (Re)Qualification of Operators
  • Categorization of Interventions
VR Simulator - Session: Understanding Human Errors and Gaining Hands-On Experience

10:30 Coffee Break

11:00 Important Aspects in Environmental Monitoring

  • TR 13 Fundamentals of an Environmental Monitoring Program
  • Regulatory Requirements and Expectations
  • Rationale for Sample Locations and Frequency
  • How to Proceed in Case of Excursions
VR Simulator - Session: Understanding Human Errors and Gaining Hands-On Experience

11:45 Team Exercise 3: Set-up an EM Program for Cleanrooms/Isolators

12:30 Lunch Break

13:30 Continue Team Exercise 3: Presentation of Results

14:00 Coffee Break

14:30 Team Exercise 4: Share your own Experience and Challenges in Aseptic Processing
- Find Resolutions as a Team

15:30 Q&A & Completion of Participant's Expectations

16:30 End of Training Course

Agenda is subject to change.

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

Melia Lebreros
C. Luis de Morales, 2
41018 Seville

Tel: +34 954 57 94 00

PDA Europe has reserved a limited number of rooms by 01 August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.

The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here
By Air The hotel is only 8 kilometers away from Seville International Airport.
By Car On site parking is available. Please contact the hotel for more information.