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PDA 260 Aseptic Process Simulation for ATMPs

Jun 06, 2023
Baltimore, MD

  • Education
  • The Americas
Closed
Program Highlights

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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, PDA Points to Consider for Microbial Control in ATMP Manufacturing, and the Annex 1 revision. The training course will address various elements required in the design and execution of aseptic process simulations for ATMPs 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.

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Agenda

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

Trainers

Ryan Murray
Ryan Murray
ValSource, Inc.
Bio
Ryan Murray
ValSource, Inc.

Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Association’s Texas Chapter and the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.
James Wamsley
James Wamsley
ValSource, Inc.
Bio
James Wamsley
ValSource, Inc.

James Wamsley has nearly 20 years experience in aseptic and low-bioburden operations, quality, training, contamination control and environmental monitoring. He spent more than 11 years at PDA's Training and Research Institute responsible for management and delivery of laboratory training courses. He has since spent time in roles with progressively more responsibility including aseptic performance improvement for clinical drug product manufacturing, development lead for contamination control and EM program at a new high-throughput SVP manufacturing facility, and as site lead for contamination control and environmental monitoring at clinical/commercial vaccine and gene therapy drug substance and drug product site.

James earned his Bachelor of Science in Biological Sciences from the University of Maryland, Baltimore County and is currently a Microbiology Consultant for 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 unique considerations for process simulations as they apply to ATMPs
    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 for ATMPs.

    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.

Hyatt Regency Baltimore Inner Harbor

300 Light Street
Baltimore, MD

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  • Accommodations
    Rate: $229 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Monday, 20 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations
    Online:     Click on the reservation link above
    Phone: +1 (410) 528-1234, make sure to give the PDA Group Code, G-GDBD, to receive the discounted conference rate

    Individual Cancellation
    48 hours prior to 23:59 local time the day of arrival or 1 night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
  • Amenities
    Experience an exceptional stay at the Baltimore Inner Harbor hotel designed for business and vacation travelers. Discover a unique blend of urban luxury and local hospitality with stylish rooms and suites that give you a sense of home and tech savvy enhancements that keep you productive. The convenient location makes it easy to walk to area museums, historic landmarks and attractions like the National Aquarium and Camden Yards. Enjoy what happens when convenience meets charm at Hyatt Regency Baltimore Inner Harbor.

How to Get Here

By Air

Baltimore/Washington International Thurgood Marshall Airport (BWI) is approximately 12 miles (20km) from the hotel and all major carriers service this airport. Taxi fares from BWI are approximately $35 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency Baltimore Inner Harbor is located at 300 Light Street, Baltimore, MD 21202. Both valet and self-parking are available.

Other Options

Hyatt Regency Baltimore Inner Harbor is conveniently located only four blocks from the Metro subway system and only three blocks from the Lightrail. BUS-MTA picks up right outside the hotel, making it easy to explore the area.

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Registration Fees

Regular Price
Registration Type Price - Spring Training Sale!
Member $1,499 $599
Non-member $1,799 $599
Gov't/Health Auth./Academic $1,049 $599

* 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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