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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Container Closure Integrity Testing Training Course

Apr 19 - Apr 20, 2018 |
Apr 20, 2018 |
Imperial Palace Seoul | Seoul, Korea
  • Education
  • Asia-Pacific
  • Western Hemisphere Events
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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

Standard

Member

$675

Nonmember

$855


Government/Health Authority/Academic

Member

$495

Nonmember*

$495


Student Member

Member

$380

Nonmember*

$425


Young Professional Member

Member

$450

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 info@pda.org or +1 (301) 656-5900.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@pda.org

  • 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
Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4231

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