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2021 PDA FDA

2021 PDA/FDA Joint Regulatory Conference

Sep 27 - Sep 29, 2021
Washington, DC

The Roaring 20s: Crisis, Collaboration, Commitment to Quality

  • Conference
  • The Americas

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Program Highlights
Registration now open!

Overview

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 30th year. This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape. Last year we explored the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Attendees will benefit through the discussion of latest innovative technologies, case studies, regulatory expectations, and forward-looking perspectives in sessions. FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates.

The conference will continue to focus on advancing quality management and the robust manufacturing of innovative drugs, biologics, and combination products. Combined efforts of industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.

Agenda Coming Soon

Networking Opportunities

 

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this conference, participants will gain skills to:

    • Conduct successful investigations of Out-of-Specification (OOS)/Out-of-Trend (OOT) findings
    • Effectively implement data integrity remediation
    • Establish robust processes and maintain state of controls
    • Improve product availability and avoid shortages
    • Manage post-approval changes and change management processes
    • Successfully implement quality management techniques and robust manufacturing
    • Update facilities to support dependable quality and supply
  • Who Should Attend

    Who Should Attend

    Departments

    Corporate Offices, Research and Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

    Job Function

    Quality Assurance | Manufacturing | Compliance/Inspection Management | Supply Chain | Auditing | Executive Management

    Academia

    Pharmaceutical sciences | Regulatory science

    Global Regulatory Authorities

Got a Question? We have answers

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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 Hotel

999 9th Street, NW
Washington, DC

  • Accommodations
    The Conference room block is not currently open. Please check back June 2021.
  • Amenities

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by 31 July 2021
Member $958
Non-member $1098
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Young Professional Member $479
Regular Registration
Registration Type Regular Registration
Price after 31 August 2021
Member $1,341 $1,724
Non-member $1,537 $1,976
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Young Professional Member $671 $862

* 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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Featured Exhibitors

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Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Media Partners

Contact

Program Inquiries
  • Molly E. O’Neill, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
  • Andrea Viera
    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
Exhibition Inquiries
Training Course Inquiries
Registration Customer Care

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

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