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PDA 374 Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products

Sep 15, 2022
Washington, DC

  • Education
  • The Americas

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Overview

The objective of aseptic processing is to prevent the microbiological contamination of sterile product manufactured using the process. The verification of the ability of the process to produce sterile product is evaluated by aseptic process simulation studies or media fills.

This training course is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The training course will address various elements required in the design and execution of aseptic process simulations to include 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.

Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

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

PDA Aseptic Processing Training Courses
PDA Regulatory Training Courses

Agenda

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

Trainers

Hal Baseman
Hal Baseman
ValSource Inc.

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. Explain why environmental monitoring is an important element of process simulations
    6. Discuss the necessary documentation associated with process simulations
    7. Apply modern concepts to establish appropriate acceptance criteria for aseptic process simulations, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions
  • Who Should Attend

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

    Departments
    Quality Control (Microbiology), Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Technical Operations, Training, Validation

    Roles
    Specialist, Operator/Technician, Supervisor, Manager, Director, Engineer, Scientist, Auditor/Inspector

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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.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $322 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, 15 August 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Set in the heart of the city, our upscale hotel is steps from Capital One Arena, Penn Quarter and the Walter E. Washington Convention Center. From museums to entertainment, this is the perfect base for exploring downtown D.C. Fuel up for a busy day downtown with breakfast weekdays at Mixx or weekends at Fifteen Squares Restaurant. Our Grand Ballroom, meeting rooms and 11th-Floor Terrace are also available for a host of multi-sensory events, from important conferences to joyful weddings. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi and suites with beautiful terraces.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Renaissance Washington, DC Downtown Hotel is located at 999 9th Street NW, Washington, DC. Parking is available onsite at the following rates: Daily Self Parking - $35 Daily Valet Parking - $60.18

Other Options

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National. Union Station is 1 mile away from the hotel. To book your reservation, call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

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Registration Fees

Early Registration
Registration Type Price By August 1, 2022
Member $699
Non-member $699
Gov't/Health Auth./Academic* $699
Regular Registration
Registration Type Price After August 1, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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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