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PDA Container Closure Integrity Testing Training Course

Apr 19 - Apr 20, 2018
Seoul, Korea

  • Education
  • Asia-Pacific
  • The Americas

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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


  • Thursday, April 19

    8:00 – 17:30 | Registration Open

    9:00 – 10:30

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    9:00 | Welcome and Introduction

    • Learning objectives

    9:30 | Regulatory Requirements

    • CCI introduction, regulatory requirements, and industry trends

    10:00 | CCI Assurance throughout Product Lifecycle

    • Container closure integrity assurance throughout product lifecycle
    • Testing requirement definition – risk-based approach
    • CCI profile and testing strategy development

    10:30 – 11:00 | Refreshment Break

    11:00 – 12:00

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    11:00 | CCI Test Methods: Fundamentals

    • Evolution of CCI testing technology
    • CCI defects and commonly used positive controls
    • “Sizing” and characterization of CCI defects
    • Physicochemical methods vs microbiological methods: differences and correlations

    12:00 – 13:00 | Networking Luncheon

    13:00 – 15:30

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    13:00 | CCI Test Methods: Overview

    • Deterministic vs. probabilistic definitions
    • Microbial and Dye Ingress Testing
    • Seal Quality Testing

    14:00 | CCI Test Technologies: Deterministic Methods

    • Tracer gas (helium leak detection)
    • Vacuum and pressure decay
    • Mass Extraction
    • Headspace analysis
    • HVLD

    15:30 – 16:00  | Refreshment Break

    16:00 – 17:30

    16:00 | Application Case Studies Presentations

    • Vacuum and pressure decay
      Instructor: Jaime Cobo Vélez, Sales and Marketing Director, Wilco AG
    • Mass extraction
      Instructor: Bill Hathaway, Senior Application Engineering Manager, Pfeiffer/ATC 
    • Headspace analysis
      Instructors: Derek Duncan, PhD, Director and Vice President, Marketing, LIGHTHOUSE Instruments and Evan Davis, Product Line Manager, LIGHTHOUSE Instruments

    17:00 | Day 1 Review

    Friday, April 20

    8:00 – 16:00 | Registration Open

    9:00 – 10:30

    9:00 | Application Case Presentations

    • Tracer gas (helium leak detection)
      Instructor: Bill Hathaway, Senior Application Engineering Manager, Pfeiffer/ATC
    • A Pre-Filled Syringe Case Study: Use Helium Leak Detection CCI Testing to Inform Container Closure System Design
      Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company
    • High Voltage Leak Detection
      Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    10:30 – 11:00  | Refreshment Break

    11:00 – 12:00

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    11:00 | Application Case Presentations

    • Residual Seal Force Testing

    11:20 | Hands-On Training

    12:00 – 13:00  | Networking Luncheon

    13:00 – 14:00

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    13:00 | Development and Validation of Integrity Test Methods

    • Method development best practices
    • Method validation strategy
    • Pitfalls and solutions

    14:00 – 14:30 | Refreshment Break

    14:30 – 16:00

    Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

    14:30 | Approaches to CCI Testing Method Selection

    • Method selection considerations
    • Introduce case study

    15:00 | Case Study Group Exercise Break-Out

    15:30 | Case Study Group Exercise - Result Review and Discussion

    15:50 | Recognition, Certification

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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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.

Imperial Palace Seoul

640 Eonju-ro, Nonhyeon-dong, Gangnam-gu
Seoul, Korea

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Registration Fees

Regular Price






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Young Professional Member



All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

You must be a member to take advantage of this rate.

REFUND FOR COURSES: If your written request is received by March 30, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.


Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: [email protected]

* 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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