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2019 ParPack

Container Closure Integrity Testing - Spring Edition

Mar 21 - Mar 22, 2019
Venice, Italy

This PDA Europe Workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle.

  • Education
  • Europe

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Program Highlights

Presentation of Technology, Instruments Demo and Hands-on Training kindly supported by:

  • Eurofins
  • Genesis Packaging Technology
  • Lenox Laser
  • Lighthouse
  • Pfeiffer Vacuum
  • pti
  • Sartorius Stedim
  • Wilco

Overview

This workshop focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The Workshop will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this Workshop, participants gain critical problem solving skillsthrough:

  • interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
  • hands-on testing training on the newest innovations and state-of-the-art instruments
  • real-world case studies.

Agenda

  • Day 1
  • Day 2
  • Thursday, 21 March 2019

    9:00
    Welcome and Introduction


    9:15
    Regulatory Requirements:
    CCI Introduction, Regulatory Requirements, and Industry Trends


    10:00
    Introduction

    • Testing requirement definition – risk based approach
    • CCI Profile & Testing strategy development
    • CCI Assurance throughout Product Lifecycle

    10:30
    Coffee Break

    11:00
    CCI Test Methods: Fundamentals

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

    11:40
    Methodologies for Sizing CCI Defects Using Gas Flow Dynamics


    12:00
    Lunch Break

    13:00
    CCI Test Methods: Overview(continued)

    • Deterministic vs probabilistic definitions
    • Physicochemical methods vs microbiological methods: differences and correlations
    • Microbial and Dye Ingress Testing Basics

    13:30
    Advanced CCI Testing Technologies

    • Vacuum and pressure decay
    • Mass Extraction
    • Headspace analysis
    • Seal Quality Testing
    • HVLD
    • Tracer gas (helium leak detection)
    • Seal Quality Testing (residual seal force)

    15:00
    Coffee Break


    15:30
    Current Topics: Industry Best-Practices and Novel Technologies

    • AMI Optical emission spectroscopy for CCI testing & demo

    16:00
    Application Case Studies (Part 1)

    • Tracer gas (helium leak detection)
    • API Container Testing using Helium leak detection & video

    Day 1 Review, Q&A


    17:00
    End of Day 1

    Friday, 22 March 2019

    8:30
    Application Case Studies (Part 2)

    • Vacuum and pressure decay
    • Mass Extraction

    9:10
    Hands-on Training


    10:10
    Coffee Break


    10:40
    Application Case Studies (Part 3)

    • Headspace analysis
    • HVLD

    11:20
    Hands-on Training


    12:00
    Lunch Break

    13:00
    Development and Validation of Integrity Test Methods

    • Method development best practices
    • Method validation strategy
    • Pitfalls and solutions
    • A Case Study

    14:10
    Approaches to CCI Testing Method Selection

    Introduce group exercise:
    Product life cycle testing and method selections


    14:30
    Coffee Break


    15:00
    Group Exercise - Breakout


    15:30
    Group Exercise - Presentations & Discussion


    16:00
    End of Workshop
  • Friday, 22 March 2019

    8:30
    Application Case Studies (Part 2)

    • Vacuum and pressure decay
    • Mass Extraction

    9:10
    Hands-on Training


    10:10
    Coffee Break


    10:40
    Application Case Studies (Part 3)

    • Headspace analysis
    • HVLD

    11:20
    Hands-on Training


    12:00
    Lunch Break

    13:00
    Development and Validation of Integrity Test Methods

    • Method development best practices
    • Method validation strategy
    • Pitfalls and solutions
    • A Case Study

    14:10
    Approaches to CCI Testing Method Selection

    Introduce group exercise:
    Product life cycle testing and method selections


    14:30
    Coffee Break


    15:00
    Group Exercise - Breakout


    15:30
    Group Exercise - Presentations & Discussion


    16:00
    End of Workshop

Trainers

Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Lei Li
Lei Li
Eli Lilly and Company

Additional Information

  • Learning Objectives

    Learning Objectives

    This workshop utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:

    • Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
    • Defining CCI requirements for various container and drug product types using a risk-based approach.
    • Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laserbased gas headspace analysis, mass extraction leak test.
    • Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
    • Defining CCI testing method development and validation approach and best practices.
    • Avoiding common issues and pitfalls in CCI testing applications
  • Who Should Attend

    Who Should Attend

    • Parenteral drug packaging engineers and formulation scientists
    • Laboratory scientific staff and managers
    • Parenteral manufacturing staff
    • Sterility Quality Assurance
    • Regulatory affair scientists
    • Pharmaceutical packaging component manufacturing staff
  • 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: Not Applicable

    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.

Hilton Molino Stucky Venice

Giudecca, 810
Venice, Italy
Phone: +39 041 272 3311

Make a Reservation
Hilton Molino Stucky Venice
  • Accommodations
    Hotel Website

    Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

    The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

    Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

    PDA Europe has reserved a limited number of rooms until the 19th December 2018.
    Book Your Room for the PDA Group Rate

    Single Room € 209 per night*
    Double Room € 239 per night*

    *Rates are per room and night, including the following services and benefits free of charge:
    • Buffet Breakfast in the restaurant
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Venice Marco Polo Airport – VCE

Airport Phone: +39 041 260 9260

By Car

Transfer per Public Boat to the Conference Venue
Distance: 17 km

Airport shuttle service:

  • Public Boat: €15 per passenger (one way)
  • Public Bus: €8 per passenger (one way)
  • Public Taxi: €35 per passenger(one way)

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (22%)

* 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 [email protected] 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 [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
[email protected]

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

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Tel: +1 (301) 656-5900 ext. 115
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