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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Container Closure Integrity Testing Training Course - Taiwan

Nov 08 - Nov 09, 2018 |
Nov 09, 2018 |
Regent Taipei | Taipei, Taiwan
  • Education
  • Asia-Pacific
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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,8-November

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 and CCI Assurance

  • Regulatory requirements
  • 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 and Overview

  • CCI defects and commonly used positive controls
  • “Sizing” CCI defects using gas flow dynamics 
  • Evolution of CCI testing technology: liquid flow, gas flow, electron flow (electric current)

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: Fundamentals and Overview

  • Deterministic vs. probabilistic definitions
  • Physicochemical methods vs microbiological methods: differences and correlations
  • Seal quality testing

14:00 | CCI Test Technologies

  • Introduce group exercise #1: method characteristics
  • Microbial and dye ingress testing basics
  • Vacuum and pressure decay
  • Mass extraction   

15:00 – 15:30  | Refreshment Break

15:30 – 17:00
Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

15:30 | CCI testing technologies

  • Headspace analysis
  • HVLD 
  • Tracer gas (helium leak detection)
  • Seal Integrity method example (residual seal force)

16:30 | Group Exercise #1

  • Method characteristics, review, and discussion

Friday, 9-November

9:00 – 10:30

9:00 | Invited Lectures

  • Vacuum and pressure decay lecture: WILCO
  • Instructor: Jaime Cobo Vélez, Sales and Marketing Director, Wilco AG
  • Headspace analysis lecture: Lighthouse
  • Instructor: Evan Davis, Product Line Manager, LIGHTHOUSE Instrument

9:45 | Hands-on training
The class will be divided into two groups to have simultaneous hands-on training. The two groups will switch at after approximately 20 minutes.

  • Vacuum and pressure decay hands-on: PTI
  • Instructor: Heinz Wolf, General Manager, PTI
  • Headspace analysis hands-on: PTI
  • Instructor: Allen Sheng, MD, Managing Director, Shanghai Zillion M&E Equipment Co., Ltd

10:30 – 11:00  | Refreshment Break

11:00 – 12:30

11:00 | Invited Lectures

  • HVLD lecture: PTI
  • Instructor: Heinz Wolf, General Manager, PTI
  • Residual seal force lecture: GIS
  • Instructor: Dong-Oh Kwon, Managing Director, GIS Korea Ltd.

11:45 | Hands-on Training
The class will be divided into two groups to have simultaneous hands-on training. The two groups will switch at after approximately 20 minutes.

  • HVLD hands-on: PTI
  • Instructor: Heinz Wolf, General Manager, PTI
  • Residual seal force hands-on: GIS
  • Instructor: Young Jun Kwon, GIS Korea Ltd.

12:30 – 13:30  | Networking Luncheon

13:30 – 14:30
Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

13:30 | Method Development and Validation

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

14:30 – 15:00 | Refreshment Break

15:00 – 16:30
Instructor: Lei Li, PhD, Engineer Advisor Delivery and Device R&D, Eli Lilly and Company

15:00 | Approaches to CCI Testing Method Selection

  • Method selection considerations
  • General approaches

15:30 | Group Exercise #2

  • Method selection and application

16:00 | Class Discussion

  • Recognition and 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 October 19, 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 Instrument
  • Heinz Wolf, General Manager, PTI
  • Allen Sheng, MD, Managing Director, Shanghai Zillion M&E Equipment Co., Ltd
  • Dong-Oh Kwon, Managing Director, GIS Korea Ltd.
  • Young Jun Kwon, GIS Korea Ltd.
Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4545

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