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PDA EU00179 Best Practices and Points to Consider in Aseptic Processing

Sep 22 - Sep 23, 2022
Amsterdam , The Netherlands

  • Education
  • Europe

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Program Highlights

This training course will have a cooperation with Sebastian Scheler from Innerpsace and it's technology.

Overview

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to 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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 22 September 2022

    9:00 Welcome and Collection of Participant Expectations


    9:30 Introductional Test about Selected Hot Topics in Aseptic Processing


    10:30 Coffee Break


    11:00 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
    • Live-Demonstration/Training of Cleaning/Disinfection Simulator module

    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

    14:30 Team Exercise 1: How to build- up and maintain an Aseptic Environment


    15:30 Coffee Break


    16:00 Effective Oversight at the shop floor, Good Training Methods

    • Regulatory requirements and framework
    • Sharing our best practices and effectiveness
    • Examples from the shop floor worldwide
    • VR Technology and Human Error Analysis

    17:45 End of Traning Course Day 1

  • Friday, 23 September 2022

    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

    10:00 Simulator-Session on assessment of mission-critical cleanroom behavior


    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
    • Live-Demonstration/Training of Simulator for Environmental Monitoring

    11:30 Team Exercise 2: Set-up an EM Program for Cleanrooms/Isolators

    Exercise: Environmental Monitoring Exam in VR Simulator


    12:30 Lunch Break


    13.30 Team Exercise 3: Share your own case studies and problems, and find resolutions as a team


    15:00 Coffee Break


    15:30 Team Exercise 4: Benchmarking between team members


    16:30 End of Training Course

Trainers

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

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
  • 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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Travel

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.

Hilton Amsterdam

Apollolaan 138
Amsterdam , The Netherlands

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Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 per night*

    * Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 01 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

    The hotel does not have a shuttle bus

    There are several options for transportation from Schiphol Airport to the hotel. Schiphol is 15KM away from the hotel, and Rotterdam 65KM.

    Limo-service

    The hotel can arrange a private driver to pick you (and fellow travellers) up. The driver will be waiting for you after luggage pick up. The price for this service is 95 euro for a sedan, 110 euro for a mini-van. If you would like to use this service, please inform the hotel at least a few days in advance.

    Car-Sharing (App & membership required)

    Sixt share cares are available at the airport and their entire fleet is hybrid. Follow the signs ‘car rental’ from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Choose your favorite car , register it on your SIXT app and exit the parking garage.

How to Get Here

By Air

The international airport of Amsterdam is "Schiphol" located 15 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). From there you can either walk for approximately 15 minutes or take tram Nr. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. From the tram stop it is about 5 minutes walking to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

* 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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