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PDA 109.1 Container Closure Systems and Integrity Testing

Aug 22 - Aug 24, 2023
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

This training course provides insight into the fast-evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. This training course introduces a practical and meaningful methodology to construct package integrity profiles using a risk-based approach and appropriate Container Closure Integrity (CCI) testing methods.

During this training course, participants will have the opportunity to not only observe on-site instrument demonstrations but to also perform various advanced CCI testing techniques to include vacuum decay, electrical conductivity and capacitance, laser-based gas headspace analysis, and mass extraction leak test. In addition, participants can take advantage of the breakout sessions to discuss topics of interest with testing experts from major instrument vendors.

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

PDA Parenteral Packaging Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Bio
Allison L. Dill
Eli Lilly and Company

Allison Dill, Ph.D. is a Principal Research Scientist in Bioproducts Research and Development at Eli Lilly and Company, Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to many regulatory submissions. Her contributions were recognized with an Eli Lilly Top 100 Innovator Award. She has contributed to the corporate CCI strategy as well as the strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection. In her current role, she provides technical leadership enabling the delivery of the bioproducts portfolio within a complex global network with responsibility for the analytical control strategy of both drug substance and drug product across all phases of development.
Coralie A. Richard
Coralie A. Richard
Eli Lilly and Company
Bio
Coralie A. Richard
Eli Lilly and Company

Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions at Eli Lilly and Company, Indianapolis, U.S.

A native from France, she came to the U.S. to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards. In her current role she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping and distribution, surface science, and several related DDCS laboratories. Her global team support clinical and commercial development activities across all business units.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Develop meaningful design requirements for maximum allowed leakage limit for various product-package types
    2. Describe working principles of various CCI testing techniques, with focus on deterministic methods, such as vacuum decay, electrical conductivity and capacitance (HVLD), laser-based gas headspace analysis, and mass extraction leak test
    3. Develop familiarity with advanced CCI testing technologies via hands-on exercises of testing representative samples
    4. Formulate a comprehensive CCI testing plan throughout product life cycle in support of package integrity verification profile
    5. Apply risk-based approaches to develop a CCI control strategy in which various CCI testing methods are used to inform, verify, and demonstrate package integrity
  • Who Should Attend

    This training course is intended for professionals who are involved in container closure integrity testing for sterile drug manufacturing.

    Departments
    Quality Control, Quality Assurance Operations, Technical Operations, Validation, Packaging

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager

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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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: 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 take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By July 08, 2023
Member $3,149
Non-member $3,779
Gov't/Health Auth./Academic $2,449
Regular Registration
Registration Type Price After July 08, 2023
Member $3,499
Non-member $4,199
Gov't/Health Auth./Academic $2,449

* 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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