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2019 UPS

Container Closure Integrity Testing – Basic Course - Fall Edition

Oct 24 - Oct 25, 2019
Gothenburg, Sweden

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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Overview

This course 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 course 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 course, 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, 24 October 2019

    9:00
    Welcome and Introduction


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


    9:45
    CCI Assurance throughout Product Lifecycle

    • Testing requirement definition – risk based approach
    • CCI Profile & Testing strategy development

    10:30
    Coffee Break

    11:00
    Introduction to Group Exercise #1:
    Product life cycle testing and method selection


    11:15
    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
    Lunch Break

    13:00
    CCI Test Methods: Fundamentals and Overview(continued)

    • Deterministic vs probabilistic definitions
    • Physicochemical methods vs microbiological methods: differences and correlations
    • Microbial and Dye Ingress Testing Basics
    • Seal Quality Testing
    • Introduction group exercise #2: Method Characteristics

    14:00
    Advanced CCI Testing Technologies

    • Vacuum and pressure decay
    • Mass Extraction
    • Headspace analysis
    • Seal Quality Testing
    • HVLD

    15:00
    Coffee Break


    15:30
    CCI Testing Technologies (continued)

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

    16:00
    Current Topics: Industry Best-Practices and Novel Technologies

    1. AMI Optical emission spectroscopy for CCI testing
    2. API Container Testing using HeLD; Review Helium leak detection video

    17:00
    Group Exercise #2: Method Characteristics

    • review, discussion

    Day 1 Review, Q&A


    17:30
    End of Day 1

  • Friday, 25 October 2019

    8:30
    Application Case Studies – Section 1

    • Vacuum and pressure decay
    • Mass Extraction

    9:10
    Hands-on Training


    9:50
    Application Case Studies – Section 2

    • Headspace analysis
    • HVLD

    10:30
    Coffee Break


    11:00
    Application Case Studies – Section 3

    • Tracer gas (helium leak detection)
    • SQT (Residual Seal Force)

    11:40
    Instrument Demo and Hands-on Training


    12:40
    Lunch Break

    13:40
    Development and Validation of Integrity Test Methods

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

    14:30
    Approaches to CCI Testing Method Selection

    • Method selection considerations
    • Class discussion - examples

    15:00
    Coffee Break


    15:30
    Group Exercise #1: Method Selection Review, Discussion, Q&A


    16:00
    Class Discussion, Recognition, Certification


    16:30
    End of Course

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 course 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.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden


    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.

    You can book your Hotel Accomodation here!

  • Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (25%)

* 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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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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