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PDA 240 Global Sterile Manufacturing Regulatory Guidance Comparison

Sep 21, 2023
Washington, DC

  • Education
  • The Americas
Cancelled

Overview

More information coming soon.

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.

Trainers

Robert Darius
Robert Darius
Sanofi Pasteur
Bio
Robert Darius
Sanofi Pasteur

Bob graduated from George Mason University and attended John Hopkins University Graduate Program. He is a Microbiologist by training. After serving in FDA Center for Biologics Evaluation and Research for 15 years as a Senior Reviewer, Lead Inspector, and Branch Chief; he served as VP Quality Operations for the German and North American Operations for 11 years at GSK Vaccines.

Prior to joining Sanofi as Head of Injectables Compliance in April 2017, he served as the SVP of Quality at Novavax. Bob is active in supporting the PDA, and developed this presentation on Lyophilization while serving in the FDA.

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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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.

Renaissance Washington, DC Downtown

999 9th Street, NW
Washington, DC

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  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

    Rate: $331 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 15:00
    Check-Out: 12:00

    Reservations

    Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
    Online:     Click on the reservation link above

    Individual Cancellation

    All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.

How to Get Here

By Air

The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).

By Car

The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.

Other Options

The metro stations closest to the Renaissance Washington, DC Downtown hotel are Mount Vernon Square (yellow/green line, 0.4m/0.6km), Gallery Place (red/yellow/green, 0.3m/0.5km), and Metro Center (red/blue/orange/silver, 0.4m/0.6km). Please visit www.wmata.com for fare and schedule information.

Directions

Registration Fees

Early Registration
Registration Type Price By August 7, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699

Regular Registration
Registration Type Price After August 7, 2023
Member $999
Non-member $1,199
Gov't/Health Auth./Academic $699

* 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].

Sponsors

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Exhibitors

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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