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

Jul 23, 2020
Raleigh, NC

  • Education
  • The Americas
Cancelled

Overview

The goal of aseptic operations is to prevent the contamination of materials intended to be sterile. For large scale automated operations where operator interventions are infrequent, the verification of the ability of the process to produce sterile products is evaluated by conduct of large-scale automated media fills in a manner analogous to normal production. Processes using all or partial manual procedures must also be evaluated by process verification testing. Such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on the individual operator proficiency. Operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during a process. Reproducible human performance cannot be assumed over time. These and other challenges posed by manual aseptic processes must be considered when designing the evaluation protocol.

This training course, based on PDA Technical Report No. 62: Recommended Practices for Manual Aseptic Processing, will provide a tutorial of suitable physical techniques, equipment uses, and processing operations that can be used to address the challenges posed in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual process simulations will be covered.

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

PDA Aseptic Processing Training Courses

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Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

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. Explain the differences between an automated process simulation vs a manual process simulation
    2. Discuss the different environments MAP can be performed in as well as the personnel training requirements specific to a MAP
    3. Recognize the application of different equipment used in a MAP and how to handle the challenges of a manual process not presented during an automated process
    4. Evaluate a MAP case study
  • Who Should Attend

    This training course is intended for professionals who are involved in manual aseptic processing.

    Departments
    Engineering, Facilities, Manufacturing, Pharmacy, Research and Development, Validation

    Roles
    Consultant, Microbiologist, Operator, Pharmacist, Scientist, Technician

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Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

How to Get Here

By Air

The closest airport to the training course location is the Raleigh-Durham International Airport (RDU).

By Car

Parking is available at prevailing rates in parking lots and decks surrounding the Raleigh Convention Center. Parking in the Loading Dock or inside the center (except for loading or unloading) is strictly prohibited and violators will be towed at owner’s expense. Please click here for parking maps and additional details.

Other Options

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Directions

Registration Fees

Regular Price
Registration Type Price
Member $999
Non-member $999
Gov't/Health Auth./Academic* $999

* 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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