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Technical Report No. 62: Recommended Practices for Manual Aseptic Processes

Nov 12 - Nov 14, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. Processes using all or partial manual procedures must be evaluated by process verification testing. However, manual operations present unique operational and evaluation challenges not generally encountered with automated operations. For instance, manual aseptic processes rely heavily on individual operator proficiency, which is generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. This and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

Based on PDA’s Technical Report No. 62: Recommended Practices for Manual Aseptic Processes, this training course will provide insight into the technological challenges associated with designing, operating and evaluating manual aseptic processes. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes at their own plants. Participants will also have the opportunity to design, test and evaluate a protocol to perform a manual process simulation.

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Trainers

Cheryl Custard
Cheryl Custard
CBC Training & Consulting
Bio
Cheryl Custard
CBC Training & Consulting

Cheryl Custard is the Principal/Owner at CBC Training & Consulting, an aseptic training and consulting company founded in 2011. She has over 20 years of industry experience in both pharmaceutical/biopharmaceutical aseptic processing, small scale aseptic processing and training & qualification requirements. Cheryl has a Masters of Science Degree from East Stroudsburg University in Pennsylvania, USA, and is an in-kind supporter of various government organizations that audit and support industry aseptic needs. Cheryl is an active member of the PDA and has been a faculty member for the 2-week Aseptic Processing training course, as well as other PDA initiatives, for the last 18 years.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the challenges associated with manual aseptic processing
    2. Describe the elements involved in the design of a manual aseptic process
    3. Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
    4. Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
    5. Design a protocol for the conduct of a process simulation test for manual processing
    6. Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who design, perform and evaluate manual aseptic processes (compounding, filling, packaging and quality operations).

    Departments
    Manufacturing, Quality Assurance, Validation, Manufacturing Technology

    Roles
    Operator, Technician, Supervisor, Manager

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: 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 do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

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.

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Registration Fees

Early Registration
Registration Type Price By September 28, 2019
Member $3,419
Non-member $4,103
Gov't/Health Auth./Academic* $2,279





Regular Registration
Registration Type Price After September 28, 2019
Member $3,799
Non-member $4,559
Gov't/Health Auth./Academic* $2,279





* 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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