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PDA 190.1 Assessing Packaging and Processing Extractables/Leachables

Oct 20, 2022
Palm Springs, CA

  • Education
  • The Americas
Closed

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.

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

PDA Parenteral Packaging Training Courses
PDA Universe of Pre-Filled Syringes and Injection Devices Training Courses

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Agenda

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

Trainers

Diane M. Paskiet
Diane M. Paskiet
West Pharmaceutical Services, Inc.
Bio
Diane M. Paskiet
West Pharmaceutical Services, Inc.

Diane Paskiet has over 30 years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and combination products. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is on the Product Quality Research Institute (PQRI)  Steering Committee and Chair of the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute. She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.
Cheryl M Stults
Cheryl M Stults
C & M Technical Consulting, LLC
Bio
Cheryl M Stults
C & M Technical Consulting, LLC

Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of combination products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification, and control. Some prior positions: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She led industry initiatives focused on pharmaceutical packaging and device materials and is a Science Advisor to IPAC-RS and ELSIE. Dr. Stults has been actively involved with the USP Packaging and Distribution Expert Committee contributing to development and revision of materials-related chapters. She holds a Ph.D. in Analytical Chemistry and completed post-doctoral studies in Biochemistry.

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

    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.

Palm Springs Convention Center

277 N. Avenida Caballeros
Palm Springs, CA

  • Accommodations

    The 2022 PDA Universe of Prefilled Syringes and Injection Devices Conference is being held at the Palm Springs Convention Center in Palm Springs, CA.

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel and the Hilton Palm Springs Hotel. The group rate at both hotels is $199 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 23 September 2022. After this date, reservations can be made on a space-and-rate available basis only.

    To make reservations, individuals may click on the reservation link below or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427 or the Hilton Palm Springs at +1 (800) 445-8667. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

    Renaissance Palm Springs Hotel

    888 Tahquitz Canyon Way
    Palm Springs, CA
    Phone: +1 (760) 322-6000
    Website | Reservations Link

    Hilton Palm Springs Hotel

    400 East Tahquitz Canyon Way
    Palm Springs, CA
    Phone: +1 (760) 320-6868
    Website | Reservations Link

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

Palm Springs International Airport (PSP) is located just minutes from downtown Palm Springs and the Convention Center. This airport is serviced by numerous carriers. Taxi fares from PSP are approximately $10 one way, not including tip, and will take about 7 minutes.

By Car

The Palm Springs Convention Center is located at 277 N Avenida Caballeros, Palm Springs, CA 92262. Parking is located to the east of the facility (Caballeros Lot) and southwest of the facility (Andreas Lot).

Other Options

N/A

Directions

Registration Fees

Early Registration
Registration Type Price By September 5, 2022
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699
Regular Registration
Registration Type Price After September 5, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* For this member type or discount, online registration is not available, please contact [email protected].

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].

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