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2023 PDA_Training-1988x680

PDA EU00179 Best Practices and Points to Consider in Aseptic Processing

Sep 14 - Sep 15, 2023
Seville, Spain

  • Education
  • Europe

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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.

Overview

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.

Agenda

  • Day 1
  • Day 2
  • 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

    • 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
    • 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

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


    15:45 Coffee Break


    16:00 Effective Shop - Floor Oversight and Good Training Methods

    • Regulatory Requirements and Framework
    • Sharing our Best Practices and Effectiveness
    • Examples from the Shop Floor Worldwide
    VR Simulator - Session: Understanding Human Errors and Gaining Hands-On Experience

    17:15 Q&A


    17:30 End of Training Course Day 1

  • 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

Trainers

Guenther Gapp
Guenther Gapp
Gapp Quality GmbH
Sebastian Scheler
Sebastian Scheler
Innerspace GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    • 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
  • Who Should Attend

    Personnel involved in Aseptic Processing from sterile production departments such as:

    • Production Management and Shop Floor Supervisors
    • QA and QC Microbiologists
    • Qualified Persons
    • Personnel from technical department

    A basic understanding of Aseptic Processing is a prerequisite.

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Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville
    Spain

    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.

  • Amenities

    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.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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