Extractables and Leachables for Parenteral Applications
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Individual Registration
Group Registration
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
- Mechanisms of Leaching and Material-Drug Product Interaction
- Analytical E/L Methodologies
- E/L Study Design for Different Packaging Systems
- Large Volume Parenterals
- Lyo Applications
Several interesting case studies on the above topics will also be presented.
- 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
Agenda
Discover What's Happening Each Day
Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.
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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.
PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD USA
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814
DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814
Please visit the hotel’s website for more information.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$2,099GovernmentMember Only
$1,259
Health AuthorityMember Only
$1,259
AcademicMember Only
$1,259
Non-Member
$2,519
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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Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the Extractables and Leachables for Parenteral Applications! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
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Boost your brand and visibility by becoming an exhibitor at the Extractables and Leachables for Parenteral Applications! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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