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PDA 343 Single Use Systems for the Manufacturing of Parenteral Products

Nov 03 - Nov 04, 2021
Bethesda, MD

  • Education
  • The Americas
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Overview

Please note that this training course will take place in person. Please read our COVID-19 Facility Access Rules before registering for this training course.

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

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  • Training courses run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Robert Repetto
Robert Repetto
Pfizer, Inc.
Bio
Robert Repetto
Pfizer, Inc.

Robert Repetto is Senior Director, External Affairs, Technical Advocacy function focused on industry and regulatory trends that enable the BioTherapeutics and Vaccine portfolio. Robert also leads Pfizer’s contract manufacturing strategy for Biosimilars

Technical Advocacy Topics of interests include: Single Use Systems, QbD, Risk Management, Biosimilar, and Innovative new therapies.

Prior to this position, Bob was Director of Technology and Innovation for Wyeth Biotech, where he was responsible for development of strategies focused on new technologies, innovation, risk management, process technology, and real time process monitoring. Robert has over 20 years of process development, manufacturing and clinical production experience with mammalian, insect and bacterial expression systems. He holds a B.E. in Chemical Engineering from Manhattan College, M.S. in Bioengineering from Polytechnic University of New York, and a MBA from Iona College.

Robert is Chairman of the PDA’s Global Taskforce for Single Use Systems.

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

    Who Should Attend

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

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

    Roles
    Manager, Specialist, Scientist, Engineer

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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 Washington/Bethesda area is serviced by the following airports: 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 do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

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 19, 2021
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic* $1,749

Regular Registration
Registration Type Price After September 19, 2021
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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