PDA 190.1 Assessing Packaging and Processing Extractables/Leachables
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Individual Registration
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This training course will provide answers to two important questions regarding extractables/leachables (E/L): “What are the current and anticipated regulations?” and “How can I perform a scientific- and risk-based assessment to meet expectations for a wide range of pharmaceutical products and delivery system.
Participants will review best practices and current trends related to designing studies and justifications for measurement of E/L from packaging and manufacturing components. The sources of extractables from materials such as plastic, glass and rubber and occurrence of leachables will be discussed. Participants will also learn how to acquire and assess E/L data to enable qualification of materials, components and systems for use throughout the lifecycle of a pharmaceutical product.
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- Discuss the evolving E/L expectations from a global perspective (US, EU, Japan, and China)
- Recognize the importance for the alignment of Leachable Safety Thresholds and Extractables Best Practices for drug products, delivery devices, and processing/manufacturing components and drug-device combination products
- Identify sources of potential leachables and impact to product quality and safety by understanding the materials being used in various applications
- Apply risk-based approaches to justify strategies for acquiring and assessing E/L
- Identify what specific E/L information must be present in the CMC sections of applications for the various types of drug products (injectables, oral, etc.)
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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.
Palm Springs Convention Center
277 N. Avenida CaballerosPalm Springs, CA , USA
The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA.
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 Palm Springs Hotel and the Hilton Palm Springs Hotel. The group rate at both hotels is $199 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 23 September 2022. After this date, reservations can be made on a space-and-rate available basis only.
To make reservations, individuals may click on the reservation link below or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427 or the Hilton Palm Springs at +1 (800) 445-8667. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.
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.
Renaissance Palm Springs Hotel
888 Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 322-6000
Website | Reservations Link
Hilton Palm Springs Hotel
400 East Tahquitz Canyon Way
Palm Springs, CA
Phone: +1 (760) 320-6868
Website | Reservations Link
Please visit the hotel’s website for more information.