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PDA Container Closure Integrity Testing Training Course

Apr 19 - Apr 20, 2018
Seoul, Korea

This 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.

  • Education
  • Asia-Pacific
  • The Americas

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Overview

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

Agenda

  • 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

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

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

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

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

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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