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Application of Quality by Design and ICH Q9 Rules to Aseptic Processes and Their Impact to Sterility Assurance

Oct 22, 2020
Washington, DC

  • Education
  • The Americas

Overview

This training course will enable participants to better use and interpret the ICH Q9 and Quality by Design (QbD) Guidelines for application in aseptic processes. Participants will learn to design and analyze their aseptic processes while considering the risk points and their management. They will also understand the impact to sterility assurance and the possibilities offered by the QbD Guidelines to improve their aseptic processes

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

PDA Quality Assurance Training Courses
PDA Annual Global Conference on Pharmaceutical Microbiology Training Courses

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Teresa Riccioni
Teresa Riccioni
Particle Measuring Systems

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply Quality by Design (QbD) Guidelines to aseptic processes
    2. Interpret the application of ICH Q9
    3. Apply risk management for aseptic processes
    4. Design an aseptic process based on QbD
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved designing and analyzing aseptic processes for drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering

    Roles
    Analyst, Supervisor, Manager, Engineer, Technician

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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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

  • 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 Grand Hyatt Washington. The rate is $299 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 21, 2020. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. 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

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001.

Self-Parking: $42 per day
Valet Parking: $62 per day

Other Options

The Hotel lobby is connected to the Metro Center Metro Station. Metro fare from Reagan National Airport (DCA) is $2.30 (one-way; Blue Line).

Directions

Registration Fees

Early Registration
Registration Type Price By September 7, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979
Regular Registration
Registration Type Price After September 7, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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.

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 Oct 08, 2020, no fee will be charged. After Oct 08, 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 Oct 08, 2020, a full refund will be given minus a $200 fee. After Oct 08, 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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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

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

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