PDA 343 Single Use Systems for the Manufacturing of Parenteral Products

Bethesda, MD
Ask a Question

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.

PDA Quality and Compliance Training Courses

  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
Event Location
PDA Training and Research Institute
4350 East West Highway, Suite 110, Bethesda, MD Get Directions

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900

Standard Pricing

Standard Member Price

$2,499

GovernmentMember Only

$1,749

Health AuthorityMember Only

$1,749

AcademicMember Only

$1,749

Non-Member

$2,999

See Qualifying Criteria for Member Types.

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].

Day 1

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.

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 , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

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.