PDA 542 Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes
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Individual Registration
Group Registration
A strong microbial monitoring plan and a leveraging/introduction of new technologies should be used for all sterile medicinal products and sterile active substances. As required by the principles of Quality Risk Management, this ensures that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product.
This training course provides tools, rationales and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging/introducing new technologies for effective sterility assurance in aseptic processes.
Specific topics include:
- FDA and EU GMPs requirements for total particle and microbial environmental monitoring for aseptic processes
- Design of an environmental monitoring plan based on risk assessment and process analysis
- New technologies and instruments for environmental monitoring: feature, scientific description and benefits
- New technologies and instruments for environmental monitoring implementation: FDA and EU GMP requirements and implementation/validation steps
- Design a microbial monitoring plan for an effective sterility assurance in aseptic processes
- Explain the implementation of new technologies for an effective sterility assurance in aseptic processes
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Standard Pricing
Standard 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 [email protected].
Day 1
Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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Request InformationPLEASE 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 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.