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Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products

Apr 02, 2020
Raleigh, NC

  • Education
  • The Americas

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Overview

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large-scale automated process simulation testing (media fills). This training course, based on PDA Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products, will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre- and post-incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

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

PDA Annual Training Course Series

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

Hal Baseman
Hal Baseman
ValSource LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations
    2. Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations
    3. Describe how to use risk management as it applies to aseptic processing simulations
    4. Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
    5. Apply modern concepts to establish appropriate acceptance criteria for media fills, evaluate the results and investigate any failures and recommend appropriate corrective and preventive actions
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in process simulation testing.

    Departments
    Engineering, Facilities, Manufacturing, Pharmacy, Process Development, Project Management, Quality Assurance, Quality Control, Regulatory Affairs, Research and Development, Validation

    Roles
    Auditor, Consultant, Director, Engineer, Manager, Microbiologist, Operator, Pharmacist, Scientist, Specialist, Supervisor, Technician

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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.

Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

  • Accommodations

    A block of rooms have been reserved for participants in three hotels within walking distance of the Raleigh Convention Center. The correlating rates listed are for single or double occupancy per night. All guestroom rates are subject to state and local taxes. Reservations must be secured by Friday, February 28, 2020. After this date, reservations can be made on a space-and-rate available basis only.

    Marriott City Center
    500 Fayetteville Street
    Raleigh, NC 27601
    Rate: $205/night

    Sheraton Raleigh
    421 South Salisbury Street
    Raleigh, NC 27601
    Rate: $209/night

    Residence Inn Downtown Raleigh
    616 South Salisbury Street
    Raleigh, NC 27601
    Rate: $213/night (rate includes daily breakfast)

  • Amenities

    Please visit the hotel’s website for more information.

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

N/A

Directions

Registration Fees

Early Registration
Registration Type Price By February 17, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979




Regular Registration
Registration Type Price After February 17, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979




* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Mar 03, 2020, no fee will be charged. After Mar 03, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Mar 03, 2020, a full refund will be given minus a $200 fee. After Mar 03, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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

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

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Tel: +1 (301) 656-5900 ext. 115
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