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PDA 100 Aseptic Processing

Mar 20 - Apr 14, 2023
Bethesda, MD

  • Education
  • The Americas
Coming Soon

Week 1 Dates: 20MAR2023 - 24MAR2023
Week 2 Dates: 10APR2023 - 14APR2023

Overview

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

This 2-week, in-depth training course will provide a comprehensive background of knowledge for professionals involved in sterile product manufacturing. This training course will help participants improve their aseptic processes and address contamination control issues that they may encounter.

During this training course, participants will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.

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. Breakfast will not be provided, but lunch will be provided.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Assess airflow visualization to limit risk for product contamination
    2. Evaluate an environmental monitoring program by collecting sampling data and interpreting trends
    3. Describe the importance of filter integrity testing for aseptic operations
    4. Develop a robust media fill protocol, including appropriate interventions, observations and documentation requirements
    5. Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
    6. Integrate sanitization techniques and disinfectant evaluation into a comprehensive contamination control program
    7. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
  • Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing.

    Departments
    Quality Control, Engineering, Manufacturing, Quality Assurance Operations

    Roles
    Analyst, Specialist, Operator/Technician, Manager, Engineer

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants $10,000

* 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
[email protected]

Registration Customer Care

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

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