Extractables and Leachables for Parenteral Applications

Bethesda, MD
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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.

  1. Identify which regulations are to be followed and what is applicable
  2. Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
  3. Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
  4. Assess the results of an E/L program from a safety perspective
  5. Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions

Standard Registration

Member Price

$2,099

GovernmentMember Only

$1,259

Health AuthorityMember Only

$1,259

AcademicMember Only

$1,259

Non-Member

$2,519

See Qualifying Criteria for Member Types.

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 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.

Agenda is subject to change.

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 110
Bethesda, 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
By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.