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PDA 800.1 Fundamentals of Aseptic Processing

Oct 12 - Oct 14, 2021
Tonganoxie, KS

  • Education
  • The Americas

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Overview

This training course will help you understand the basic principles, processes and systems related to aseptic processing.

During this training course, you will learn about environmental monitoring systems, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, performing aseptic processes in ISO 5 conditions and performing visual inspection.

Agenda

  • This training course generally runs from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Paul Bilotti
Paul Bilotti
Wilco AG
Mary Carver
Mary Carver
Pharma Microbiology Consulting, LLC
Wayne Garafola
Wayne Garafola
Sartorius-Stedim Biotech
Sean Kerrigan
Sean Kerrigan
STERIS
John Lyons
John Lyons
Integrated Project Services (IPS)
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Evaluate current aseptic processing procedures
    2. Assess potential risks of product contamination using airflow visualization techniques
    3. Determine the necessary components of an effective environmental monitoring program
    4. Describe the importance of filter integrity testing
    5. Examine cleanroom fill operations to ensure appropriate interventions and observations occur
    6. Review basic microbiology concepts and techniques to multiple aspects of aseptic processing
    7. Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
    8. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are new to sterile drug manufacturing.

    Departments
    Quality Systems, Quality Compliance, Manufacturing, Quality Assurance Operations, Technical Operations, Validation

    Roles
    Analyst, Specialist, Supervisor, Manager, Scientist

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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.

Biomedical Devices of Kansas

1205 US-24
Tonganoxie, KS

How to Get Here

By Air

The closest airport to the training course location is the Kansas City International Airport (KCI).

By Car

There is a parking lot available at the training course location.

Other Options

N/A

Directions

Registration Fees

Early Registration
Registration Type Price By August 28, 2021
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749

Regular Registration
Registration Type Price After August 28, 2021
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic* $1,749

* 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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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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