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2019 PDA/FDA Joint Regulatory Conference

2019 PDA/FDA Joint Regulatory Conference

Sep 16 - Sep 18, 2019
Washington, DC

Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision

  • Conference
  • Western Hemisphere Events

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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 28th 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 compliance issues in an ever-evolving landscape.

This year’s theme is “Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision,” and the Conference will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Plenary and concurrent sessions will delve into the details through the assessment of latest innovative technologies, case studies and regulatory expectations, and forward-looking perspectives, including:

  • CGMP challenges associated with cell and gene therapies
  • Combination products and connected care applications
  • Compliance updates and case studies
  • Data integrity remediation and an update on the associated PDA Technical Report
  • Designing aseptic processes to reduce quality risk
  • Effective internal and external audits
  • Evolving approaches to quality management systems
  • Improving deviation and failure investigations
  • Strategies for continuous improvement of facilities and equipment
  • Use of augmented reality and artificial intelligence in manufacturing

This year’s Conference focuses on advances in manufacturing, quality, compliance advancing the continued supply 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.

Attendees will also learn about hot topics, such as inspection updates, laboratory controls, rapid microbiological methods, optimizing regulatory submissions, conducting effective smoke studies, and quality trending. Interest groups will meet to discuss in-depth regulatory and compliance issues. The Center Updates – the traditional FDA presentations from eh of the medical product Centers – will return this year. Here, FDA senior Center officials will discuss Center-specific initiatives and as provide compliance updates. The lineup of speakers also includes regulators from agencies around the world and industry leaders who will explore the global regulatory issues facing industry. And, the Breakfast with the Regulators session will return by popular demand this year.

Agenda Coming Soon

Networking Opportunities

Monday Evening Reception

7:00 p.m. - 10:00 p.m.

Unwind from a busy first day during the Monday Evening Reception! Use this time to catch up or make new connections with colleagues, peers, and suppliers over food and drinks.

Additional Information

  • Learning Objectives

    Learning Objectives

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

    • Improve data integrity
    • Assure product availability and avoid shortages
    • Establish robust processes and maintain a state of control
    • Scoping and initiating investigations for OOS/OOT findings
    • Successfully implement innovative products and manufacturing operations
    • Manage post-approval changes
    • Update facilities to support dependable quality and supply
  • Who Should Attend

    Who Should Attend

    Departments: Research and Development | Regulatory Affairs | Manufacturing | Quality | Assurance/Control | Marketing | Sales

    Job Function: Compliance/Inspection Management | Supply Chain | Auditing | Executive Management

    Academia: Pharmaceutical sciences | Regulatory science

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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 St NW
Washington, DC

Make a Reservation
Renaissance Washington, DC Downtown Hotel
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities

    The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

How to Get Here

By Air

Area Airports

Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation

Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

By Car

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking

$35 / Daily Self-Parking
$45 / Daily Valet Parking

Other Options

Metro

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train

Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com.

Directions

Registration Fees

Early Registration
Registration Type Price by July 30
Conference Conference + Workshop
Member $2,395 $3,740
Non-member $2,674 $4,219
Young Professional Member $1,198 $1,946
Gov’t/Health Auth. Member $700 $1,400
Gov’t/Health Auth. Non-member* $700 $1,500
Academic Member $700 $1,400
Academic Non-member* $800 $1,600
Student Member $280 $560
Student Non-member* $310 $620





Regular Registration
Registration Type Price after July 30
Conference Conference + Workshop
Member $2,995 $4,640
Non-member $3,274 $5,119
Young Professional Member $1,489 $2,337
Gov’t/Health Auth. Member $700 $1,400
Gov’t/Health Auth. Non-member* $700 $1,500
Academic Member $700 $1,400
Academic Non-member* $800 $1,600
Student Member $280 $560
Student Non-member* $310 $620
One Day Only Registration
Monday/Tuesday Only
Member $1,398
Non-member $1,510







* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

Sponsors

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Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

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.

Become an Exhibitor

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Media Partners

Contact

Program Inquiries
  • Molly O’Neill Moir, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
    moir@pda.org

  • Jason E. Brown
    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
    brown@pda.org

Exhibition Inquiries
  • David Hall
    Vice President
    Tel: +1 (301) 656-5900 ext. 160
    hall@pda.org

Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
    ko@pda.org

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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