PDA Container Closure Integrity Testing Training Course
Registration Options
Individual Registration
Group Registration
The PDA Container Closure Integrity Testing Training Course utilizes lectures, instrument demonstrations, hands-on testing exercises, case studies, and interactive group discussions to provide insight into the fast-evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. The 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.
Key topics include:
- Up-to-date regulatory and pharmacopeia requirements on CCI
- CCI requirements for various container and drug product types using a risk-based approach
- Principles of various CCI testing techniques and their practical applications
- Testing method selection for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles
- CCI testing method development, validation approach and best practices
- Common issues and pitfalls in CCI testing applications
The Course provides on-site instrument demonstrations and hand-on testing experience of various advanced CCI testing techniques, including 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, such as PTI, ATC, and Lighthouse.
Who Should Attend
Parenteral drug packaging engineers and formulation scientists; Laboratory scientific staff and managers; Parenteral manufacturing Staff; Sterility Quality Assurance; Regulatory affair scientists; CMC Project Management; Pharmaceutical packaging component manufacturing staff
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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].
Day 1
Thursday, April 19
8:00 – 17:30 | Registration Open
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9:00 – 10:30 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company 9:00 | Welcome and Introduction
9:30 | Regulatory Requirements
10:00 | CCI Assurance throughout Product Lifecycle
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10:30 – 11:00 | Refreshment Break
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11:00 – 12:00 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company 11:00 | CCI Test Methods: Fundamentals
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12:00 – 13:00 | Networking Luncheon
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13:00 – 15:30 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company 13:00 | CCI Test Methods: Overview
14:00 | CCI Test Technologies: Deterministic Methods
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15:30 – 16:00 | Refreshment Break
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16:00 – 17:30 |
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16:00 | Application Case Studies Presentations
17:00 | Day 1 Review |
Friday, April 20
8:00 – 16:00 | Registration Open
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9:00 – 10:30 |
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9:00 | Application Case Presentations
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10:30 – 11:00 | Refreshment Break
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11:00 – 12:00 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company
11:20 | Hands-On Training |
12:00 – 13:00 | Networking Luncheon
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13:00 – 14:00 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company 13:00 | Development and Validation of Integrity Test Methods
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14:00 – 14:30 | Refreshment Break
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14:30 – 16:00 |
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Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company 14:30 | Approaches to CCI Testing Method Selection
15:00 | Case Study Group Exercise Break-Out 15:30 | Case Study Group Exercise - Result Review and Discussion 15:50 | Recognition, Certification |
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Request InformationPLEASE 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.
Imperial Palace Seoul
640 Eonju-ro, Nonhyeon-dong, Gangnam-guSeoul, Korea ,
- Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company
- Jaime Cobo Vélez, Sales and Marketing Director, Wilco AG
- Evan Davis, Product Line Manager, LIGHTHOUSE Instruments
- Derek Duncan, PhD, Director and Vice President, Marketing, LIGHTHOUSE Instruments
- Bill Hathaway, Senior Application Engineering Manager, Pfeiffer/ATC