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PDA EU00131 Best Practices and Points to Consider in Aseptic Processing

Sep 22 - Sep 23, 2022
Amsterdam , The Netherlands

  • Education
  • Europe

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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 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.

Agenda

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

    Welcome and Collection of Expectations of Participants

    Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

    Aspects of Clean Room Concepts and Good Aseptic Working Practices

  • Friday, 23rd September 2022

    Best Practices in Aseptic Processing Simulation

    Effective Oversight at the Shop Floor, Good Training Methods

    Important Aspects in Environmental Monitoring

Trainers

Guenther Gapp
Guenther Gapp
Gapp Quality 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
  • 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.

How to Get Here

By Air

The international airport of Amsterdam is "Shiphol" located 66 km away from the hotel and conference space.

By Car

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

Other Options

From international airport "Shiphol" you can take the bus every 8 minutes, taking approximately 35 minutes to the station "Emmastraat". From here it is only a 7 min walk by foot.

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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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