PDA 452 Application of Quality by Design and ICH Q9 Rules to Aseptic Environmental Monitoring and their Impact to Sterility Assurance
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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
- Apply Quality by Design (QbD) Guidelines to aseptic processes
- Interpret the application of ICH Q9
- Apply risk management for aseptic processes
- Design an aseptic process based on QbD
Agenda
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Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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Venue Details and Accommodations
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 Street NWWashington, DC USA
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A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $309 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 6, 2021. 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.
Please visit the hotel’s website for more information.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
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 registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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