PDA 109.1 Container Closure Systems and Integrity Testing
Registration Options
Individual Registration
Group Registration
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.
Upon completion of this training course, the attendee will be able to:
- Develop meaningful design requirements for maximum allowed leakage limit for various product-package types
- 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
- Develop familiarity with advanced CCI testing technologies via hands-on exercises of testing representative samples
- Formulate a comprehensive CCI testing plan throughout product life cycle in support of package integrity verification profile
- 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
For more options and/or related training courses, please visit the following page(s):
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Standard Registration
Member Price
$3,499GovernmentMember Only
$2,449
Health AuthorityMember Only
$2,449
AcademicMember Only
$2,449
Non-Member
$4,199
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 registration@pda.org.
Featured Trainers
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Allison L. Dill, PhD
Eli Lilly and Company
Read BioAllison L. Dill, PhD
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.
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Coralie A. Richard, PhD
Eli Lilly and Company
Read BioCoralie A. Richard, PhD
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.
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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
Accommodations
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