PDA 190.1 Assessing Packaging and Processing Extractables/Leachables

Phoenix, AZ
89 days left to save!
Ask a Question

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.

Upon completion of this training course, the attendee will be able to:

  1. Discuss the evolving E/L expectations from a global perspective (US, EU, Japan, and China)
  2. 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
  3. Identify sources of potential leachables and impact to product quality and safety by understanding the materials being used in various applications
  4. Apply risk-based approaches to justify strategies for acquiring and assessing E/L
  5. 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.)

For more options and/or related training courses, please visit the following page(s):

Early Registration

Register by 09 September 2024

Member Price

$899

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,079

Standard Registration

Register after 09 September 2024

Member Price

$999

GovernmentMember Only

$699

Health AuthorityMember Only

$699

AcademicMember Only

$699

Non-Member

$1,199

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].

Featured Trainers

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.

Phoenix Convention Center - South Building

33 S 3rd Street
Phoenix, AZ 85004, USA

In Greater Phoenix, innovation is a way of life. Since ancient times, the Sonoran Desert has evoked inspiration, adaptation, collaboration, and innovation. This spirit is an indelible part of the identity and inspires the approach to agriculture, technology, sustainability, hospitality, education, medicine, business and so many other aspects that continue to shape Phoenix's future.

The result? Business is booming in the nation’s fifth-largest city. Technological and software companies are putting down roots at a rapid pace. Leading minds in energy, medicine, transportation, and other industries see Phoenix as a landscape for turning cutting-edge ideas into tools and products that the world benefits from!

Additional Hotel Information

Renaissance Phoenix Downtown (HQ)
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Westin Downtown Phoenix
  • Rate: $289 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Residence Inn Phoenix Downtown
  • Rate: $279 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024
Courtyard Phoenix Downtown
  • Rate: $269 + taxes/fees
  • Cut-Off Date: Friday, 20 September 2024
  • Room Block Opens: Monday, 10 June 2024

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.

How to Get Here
By Air The closest airport to the Phoenix Convention Center - South Building is the Phoenix Sky Harbor International Airport (PHX - approx. 4 miles/6 km).
By Car The Phoenix Convention Center - South Building is located at 33 S 3rd Street, Phoenix, AZ 85004.