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2020 CCIT

Container Closure Integrity Testing for the Advanced User

Feb 27 - Feb 28, 2020
Wohlen, Switzerland

  • Education
  • Europe

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Program Highlights
This Course will take place at the Wilco AG facilities.
Participants are encouraged to bring their own samples for discussion!

Overview

This two-day training course provides detailed insights on Container Closure Integrity Testing (CCIT) on an advanced level. Participants will earn all about the development of container closure systems for sterile drug products throughout shelf-life.

Subject matter experts present the latest regulatory landscape and industry expectations for CCIT. Additionally, best practices for methods development, testing technologies, test set-ups, as well as the creation and handling of positive control samples are shown.

The course takes place at the Wilco facility in Wohlen/Switzerland and includes hands-on learning sessions for different types of equipment.
Participants are encouraged to bring their own samples for discussion!

Agenda

  • Day 1
  • Day 2
  • Thursday, 27 February 2020

    9:00
    Welcome and Introduction


    9:15
    Regulatory Requirements:

    • USP<1207>
    • EU Annex 1
    • ICH Q9

    9:45
    Technology Overview

    • Differential pressure
    • High voltage
    • Headspace analysis

    10:30
    Coffee Break

    10:45
    Test Method Selection

    • Understanding and application of relevant criteria
    • Adapted feasibility approach

    11:15
    QC Lab or 100% Inspection

    • Differences in scale-up
    • Risk assessment
    • 2 views: technological (capabilities), external or internal requirement

    11:45
    Positive Controls

    • Types
    • Preparation
    • Pros and Cons
    • Verification with He Mass spec.

    12:15
    Lunch Break

    13:15
    Method Development

    • Feasibility
    • Fixture qualification
    • Method qualification
    • Test method validation

    13:45
    Lab Session 1 (Hands-on)

    • Operation of lab equipment
    • Daily business considerations
    • Considerations on installation site
    • Method development

    14:45
    Coffee Break


    15:00
    In-line Operation Session 1 (Hands-on)

    • Operation of inline equipment
    • Daily business considerations
    • Considerations on installation site
    • Method development

    16:00
    Facility Tour


    17:00
    Wrap-up Day 1

  • Friday, 28 February 2020

    8:30
    Recap Day 1 & Open Questions


      8:45
      Lab Session 2 (Hands-on)

      • Operation of lab equipment
      • Daily business considerations
      • Considerations on installation site
      • Method development

      9:45
      Coffee Break


      10:00
      In-line Operation Session 2 (Hands-on)

      • Operation of inline equipment
      • Daily business considerations
      • Considerations on installation site
      • Method development

      11:00
      Interactive Workshop on Best Practices

      • Feasibility trials
      • Implementation
      • Day to day use
      • Maintenance
      • Change Control

      12:00
      Lunch Break

      13:00
      Lab Session 2 (Hands-on)

      • Operation of lab equipment
      • Daily business considerations
      • Considerations on installation site
      • Method development

      14:00
      In-line Operation Session 2 (Hands-on)

      • Operation of inline equipment
      • Daily business considerations
      • Considerations on installation site
      • Method development

      15:00
      Wrap-up


      15:30
      End of Course

    Additional Information

    • Learning Objectives

      Learning Objectives

      After completion of the course the participants

      • understand the regulatory environment on an advanced level
      • can explain strengths and weaknesses of the technologies in detail
      • can select the appropriate method
      • understand different concepts of positive controls and can evaluate the pros and cons of different positive control strategies
      • understand and apply method development
      • understand and operate the methods on an advanced level
      • are enabled to evaluate their QC approach themselves
    • Who Should Attend

      Who Should Attend

      • R+D Scientists
      • Manufacturing Supervisors
      • QA Managers
      • Manufacturing Managers
      • QC Managers
      • Auditors
      Prerequisites: Basic understanding and practical experience with Container Closure Integrity Testing Technologies (as conveyed in the PDA course ‘Introduction to Container Closure Integrity Testing Technologies ’).
    • Accreditation

      Accreditation

      NOTE   Continuing education credits are not available for this event.

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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.

    Wilco AG

    Rigackerstrasse 11
    Wohlen, Switzerland
    Phone: +41 56 618 43 43

    • Accommodations

      Hotels Nearby
      PDA Europe recommends the reservation at one of the following hotel.
      The general terms of business are valid at the event hotels.


      Mercure Lenzburg Krone
      Kronenplatz 20
      5600 Lenzburg
      Switzerland
      E-Mail
      Tel: +41 62 886 65 65

      The Mercure Hotel Krone is situated below Lenzburg Castle, on the edge of the Old Town. It offers traditional yet creative cuisine and free parking in the garage.Many cosy corners and the terrace provide for an intimate atmosphere in the charming restaurant.The rooms are spacious and feature a balcony. Rooms with connecting doors are available on request.

    • Amenities

    How to Get Here

    By Air

    From Basel Airport:

    Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 74km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 50-60 minutes to the hotel.


    From Zurich Airport:

    Zurich airport (ZRH) is situated approximately 44km from the hotel. A direct bus (Line S2) runs every 30 minutes taking you to the Zurich train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 50-60 minutes to the hotel.

    By Car

    From Basel Train Station:

    From SBB train Station there is a direct train IR37 to Lenzburg train Station.


    From Zurich Train Station:

    From Zurich train Station there is a direct train IR37 to Lenzburg train Station

    Other Options

    From Basel Airport:

    Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 74km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 50-60 minutes to the hotel.


    From Zurich Airport:

    Zurich airport (ZRH) is situated approximately 44km from the hotel. A direct bus (Line S2) runs every 30 minutes taking you to the Zurich train Station, from which there is a direct train IR37 to Lenzburg train Station. A taxi takes approximately 30-40 minutes to the hotel.

    Directions

    Registration Fees

    Regular Price
    Registration Type Price
    All Participants €1.595

    All fees given in Euro and excluding VAT (7,7 %)

    * 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.

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