The Impact of CGMPs on Biomanufacturing Facility Design and Operation - Option 2

Bethesda, MD
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The global growth of biologic platforms in the manufacturing of human therapeutic products has placed an increased emphasis on understanding the impact of current Good Manufacturing Practice on facility design and operation. New product and technology platforms are pushing the boundaries of our comfort zone in understanding the impact of the GMPs on facility attributes and risk mitigation.

This training course will help you identify the current global landscape of GMPs and focus on the basis of GMP implementation, risk and impact assessment, product-process-facility attributes, and some general considerations in global GMP guidelines. During this training course, you will use case study examples and interactive exercises to interpret and apply the GMPs on biomanufacturing facility design and operation.

  1. Identify key areas of GMP definition that impact facility design, equipment design, operational approach, and facility logistics and compliance
  2. Identify the key areas of risk associated in biomanufacturing related to facility design and operational approach
  3. Apply current regulatory trends and fundamentals to develop concepts for biomanufacturing facility design that meet global regulatory guidelines

Standard Pricing

Standard Member Price

$1,399

GovernmentMember Only

$839

Health AuthorityMember Only

$839

AcademicMember Only

$839

Non-Member

$1,679

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 run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.

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

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

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.