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Assessing Packaging and Processing Extractables/Leachables

Oct 07, 2020
Las Vegas, NV

  • Education
  • The Americas

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Overview

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.

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Additional Information

  • Learning Objectives

    Learning Objectives

    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.)
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in packaging science, drug manufacturing, toxicology, drug formulation, material and component supply, CMC and DMF writing, regulatory affairs, analytical chemistry and material science.

    Departments
    Quality Control (Analytical), Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Regulatory Affairs, Supply Chain, Packaging

    Roles
    Analyst, Specialist, Supervisor, Manager, Director, Engineer, Scientist, Auditor/Inspector

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Travel

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.

Rio All-Suites Hotel and Casino

3700 W Flamingo Road
Las Vegas, NV

  • Accommodations

    Rio All-Suites Hotel and Casino
    3700 W Flamingo Road
    Las Vegas, NV 89103

    The PDA room block is not currently open. Please check back April 6, 2020.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The nearest airport to the training course location is the McCarran International Airport (LAS).

By Car

Free valet or self-parking is available for both registered and non-registered guests.

Other Options

N/A

Directions

Registration Fees

Early Registration
Registration Type Price By August 23, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price By August 23, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Sep 07, 2020, no fee will be charged. After Sep 07, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Sep 07, 2020, a full refund will be given minus a $200 fee. After Sep 07, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]org. Phone messages are not accepted.

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Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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