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PDA 343 Single Use Systems for the Manufacturing of Parenteral Products

Nov 14 - Nov 15, 2023
Bethesda, MD

  • Education
  • The Americas
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Overview

Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a Single Use System (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.

Based on PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing, this training course will provide attendees with critical concepts to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized, small molecules and for bioprocesses that produce large-molecule, biopharmaceutical products.

The training course will discuss SUSs that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.

Participants will also receive a free copy of PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.

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

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Peter J. Makowenskyj
Peter J. Makowenskyj
G-CON Manufacturing, Inc.
Bio
Peter J. Makowenskyj
G-CON Manufacturing, Inc.

Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within the industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and has helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know-how.

Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received his MEng in Chemical Engineering from Cornell University. He is also very active within PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the necessary considerations and steps to accomplish a successful evaluation and implementation of an SUS strategy
    2. Define process operating parameters and requirements necessary when examining single use solutions
    3. Compare and contrast single use technology and multi-use technology
    4. Assess risk by considering the potential for the SUS to interact with product or process fluids
    5. Outline supplier control strategies to ensure successful SUS implementation
  • Who Should Attend

    This training course is intended for professionals who are involved in the implementation of Single Use Systems for drug substance and drug product manufacturing.

    Departments
    Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Supply Chain, Product Development

    Roles
    Specialist, Manager, Engineer, Scientist

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: 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 take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

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 30, 2023
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic $1,749
Regular Registration
Registration Type Price After September 30, 2023
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic $1,749

* 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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