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PDA 800.2 Fundamentals of Aseptic Processing

Dec 12 - Dec 14, 2023
Carlsbad, CA

  • Education
  • The Americas
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Overview

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Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

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, 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.

For more options and/or related training courses, please visit the page(s) below.

PDA Aseptic Processing Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

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

    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.

Excite Pharma Services

1958 Kellogg Avenue
Carlsbad, CA

How to Get Here

By Air

The nearest airport to the training course location is the San Diego International Airport (SAN).

By Car

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

Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price By October 28, 2023
Member $3,599
Non-member $4,319
Gov't/Health Auth./Academic $2,799

Regular Registration
Registration Type Price After October 28, 2023
Member $3,999
Non-member $4,799
Gov't/Health Auth./Academic $2,799

* 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

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10
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Tel: +1 (301) 656-5900 ext. 115
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