Extractables/Leachables for Parenteral Applications Training Course (PDA 577)
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
OVERVIEW
When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in
its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues, i.e. for biopharmaceuticals, have become an additional
concern.
This training course will look at Extractables and Leachables (E/L) from many different angles:
- Regulatory Requirements and Guidelines eg. USP <1663> (Extractables Testing), USP <1664> (Leachables Testing), USP <661> (Plastic Packaging Systems), USP<665> versus BPOG (for Single Uses Systems)
- Material & Polymer Science, the Composition of Polymers
- Mechanisms of Leaching and Material-Drug Product Interaction
- Analytical E/L Methodologies, Strengths and Limitations
- E/L Study Design for Different Packaging Systems
- (Bio)Manufacturing Equipment: Implementing USP<665> and USP<1665>
- Large Volume Parenterals and Simulation Studies
- The specific E/L concerns for Lyophilized Drug Products
- Combination Products and their Specific E/L-Considerations
Several interesting case studies on the above topics will also be presented.
LEARNING OBJECTIVES
Upon completion of this event, the attendee will be able to:
- Identify which regulations are to be followed and what is applicable
- Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
- Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
- Assess the results of an E/L program from a safety perspective
- Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions
WHO SHOULD ATTEND
This event is intended for professionals who are involved in sterile drug manufacturing.
RELATED EVENTS
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Location and Travel
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.
PDA Training and Research Institute - Bethesda
4350 East West Highway, Suite 110Bethesda, MD 20814 USA
Accommodations
The following hotels are located near the event location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott
7335 Wisconsin Avenue
Bethesda, MD 20814
How to Get Here
Registration
Pricing Options
Early Registration
Register by 30 March 2026
Member Price
$1,349GovernmentMember Only
$1,049
Health AuthorityMember Only
$1,049
AcademicMember Only
$1,049
Non-Member
$1,619
Standard Registration
Register after 30 March 2026
Member Price
$1,499GovernmentMember Only
$1,049
Health AuthorityMember Only
$1,049
AcademicMember Only
$1,049
Non-Member
$1,799
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.
Become a Sponsor and/or Exhibitor
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