PDA 515 The Impact of CGMPs on Biomanufacturing Facility Design and Operation

Washington, DC
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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.

Upon completion of this training course, the attendee will be able to:

  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

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

Early Registration

Register by 29 July 2024

Member Price

$899

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,079

Standard Registration

Register after 29 July 2024

Member Price

$999

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,199

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].

Agenda is subject to change.

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Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.

Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to the CityCenterDC outdoor shopping area, the best of the city awaits outside the doors. Unwind in inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The hotel’s complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.

Additional Hotel Information

  • Rate: $331 plus applicable taxes and fees (currently 15.95%)
  • Cut-Off Date: Friday, 09 August 2024
How to Get Here
By Air The Westin Washington, DC Downtown is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 34 miles/55 km).
By Car The Westin Washington, DC Downtown is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($48+/day) and valet parking ($65+/day) are available.
By Other Options The Westin Washington, DC Downtown is easily accessible from the following Metro stops: Gallery Place-Chinatown (Green, Red, and Yellow Lines, 7th St. & H St., NW exit - approx. 0.2 miles/0.3 km) and Metro Center (Blue, Orange, Red, and Silver Lines, 11th St. and G St., NW exit - approx. 0.4 miles/0.6 km).