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2020 PDA Cell Therapy Control Strategy Workshop

Jun 23, 2020
Washington, DC

  • Conference
  • Workshop
  • The Americas

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Overview

This one-day workshop will provide hands-on, practical exercises in control strategy development for those involved in the cell therapy manufacturing field. Learn best practices for identifying target product profiles, quality target product profiles, critical quality attributes, material attributes, and critical process parameters and controls, while accounting for current regulatory framework and guidelines.

Agenda

  • Tuesday, June 23

    7:15 a.m. – 4:45 p.m. | Registration Open

    7:15 a.m. – 8:15 a.m. | Continental Breakfast

    8:15 a.m. – 8:30 a.m. | Welcome and Opening Remarks from Workshop Chair

    8:30 a.m. – 10:00 a.m. | Laying the Control Strategy Foundation

    Interactive Discussion on Lifecycle, Target Product Profile (TPP), and Quality Target Product Profile (QTPP)

    10:00 a.m. – 10:30 a.m. | Refreshment Break

    10:30 a.m. 11:00 a.m. | Defining Critical Quality Attributes (CQA)

    Interactive Discussion on Critical Quality Attributes

    11:00 a.m. 11:30 a.m. | Control Strategy Development Hands-On Exercise 1

    11:30 a.m. 12:00 p.m. | Control Strategy Development Exercise 1: Report Out

    12:00 p.m. – 1:00 p.m. | Network Lunch

    1:00 p.m. 2:00 p.m. | Developing the Control Strategy

    Interactive Discussion on Critical Product Parameters (CPP), Critical Material Attributes (CMA), and Associated Risk Assessments

    2:00 p.m. 2:45 p.m. | Control Strategy Development Hands-On Exercise 2

    2:45 p.m. – 3:15 p.m. | Refreshment Break

    3:15 p.m. 3:45 p.m. | Control Strategy Development Exercise 2: Report Out

    3:45 p.m. 4:45 p.m. | Workshop Close out and Final Thoughts

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this Workshop, you will be able to:

    • Apply specific QbD elements to cell therapy applications
    • Apply risk management tools to identify the attributes related to the product and process
    • Understand the relationships linking product profile to quality attributes
    • Understand the relationships linking product attributes to material attributes and process parameters
    • Develop potential mitigation strategies for risks related to process or product
    • Apply the knowledge to development of early-stage cell therapy based on established concepts
    • Author a control strategy that incorporates the product and process understanding from development stage studies
    • Understand how to ensure that the control strategy can be successfully managed as your product evolves
  • Who Should Attend

    Who Should Attend

    All Job Levels

    Scientist | Process and Development Engineers | Project Management | Technical Services | Supply Chain | Manufacturing | Application | Risk Management

    Departments

    Manufacturing | Product Development | Quality | Research & Development | Regulatory Affairs | Engineering | Laboratory | Science | Analytical Development & Quality Control | Information Technology | Validation | Training | Clinical

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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.

Washington Marriott Wardman Park

2660 Woodley Road, NW
Washington, DC
Phone: 877-212-5752

Make a Reservation
Washington Marriott Wardman Park
  • 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 Marriott Wardman Park Hotel. The rate is $269 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, May 29, 2020. 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 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Wardman Park Hotel at +1 (877) 212-5752. Be 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 in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Washington Marriott Wardman Park is perfectly situated in the historic center of D.C. Our hotel is conveniently located in iconic Woodley Park and adjacent to the Metro. Take on all of D.C. and enjoy our Adams Morgan neighborhood with ease from our hotel. Our grand hotel is the ideal place to enjoy the sophistication of Washington, D.C. style, coupled with modern design and amenities. Our redesigned ballroom, hotel rooms and thoughtful perks are designed to serve the needs of every traveler. Let us bring your vision of success to reality as our meeting rooms, collaboration spaces, and pop-up lounges come to life. Attendees will delight in a haven in the city as they enjoy beautifully landscaped grounds, modern guest rooms, newly redesigned ballroom, exceptional restaurants, and newly redesigned lobby bar.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 7 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 25 miles away, and Baltimore-Washington International Airport (BWI), 30 miles away.

Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 30 minutes. One way taxi fares from IAD is approximately $60 and from BWI about $88.

By Car

The Wardman Park Hotel is located at 2660 Woodley Park Road NW, Washington, DC 20008.

$48 (per day) Self-Parking. $55 (per day) Valet Parking.

Other Options

The Hotel is located .1 mile from the Woodley Park-Zoo/ Adams Morgan (Red line) Metro Station. Metro fare from Reagan National Airport (DCA) is $1.7 (one-way).

Directions

Registration Fees

Regular Price
Registration Type  
Member $1,095
Non-member $1,095














* 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 [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by May 22, 2020, no fee will be charged. After May 22, 2020, 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 by May 22, 2020, a full refund will be given minus a $200 fee. After May 22, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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