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2020 ParPack

Container Closure Development - Spring Edition

Feb 27, 2020
Basel, Switzerland

This one-day training course will cover the relevant issues of container closure development.

  • Education
  • Europe

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Overview

The course will give an overview on how to develop a container closure system for parenteral products. Starting with setting up of a product profile of the final product container, all aspects will be covered like selection of materials, assessment of container closure systems, specification and documentation of components and entire systems. In addition, current hot topics such as glass delamination and container closure integrity testing will be discussed.

For all topics of the agenda presentations will be given. The participants are invited to add own experience, ask questions and offer issues to be discussed within the group and/or with the trainer. The intention is to work in an open workshop-like atmosphere.

Agenda

  • Thursday, 27 February 2020

    9:00
    Welcome & Introduction


    9:30
    Definitions

    • Compendial definition
    • Functional definition
    • Components vs CCS
    • Description of options
    • Materials

    9:45
    Regulatory Background

    • Ph.Eur.
    • USP
    • JP
    • FDA Guideline
    • EU Directive
    • Relevant eCTD sections

    10:45
    Coffee Break

    11:15
    Development of Container Closure Systems

    • Set-up of target profile
    • Packaging materials
    • Modification of materials
    • Extractables & Leachables (E&L) testing
    • Permeability
    • Light transmission
    • Processability
    • Functional testing
    • Container closure integrity (CCI)
    • Shipping assessment
    • Combination products

    12:30
    Lunch Break


    13:30
    Workshop: Develop Your CCS


    15:00
    Coffee Break


    15:30
    Presentation of Workshop Results


    16:00
    Setting of Specifications / Submission Documentation

    • Technical/ Quality specification
    • Regulatory specification
    • Technical drawing
    • Regulatory drawing
    • DMF for US submission

    16:30
    Wrap-up and Final Q&A


    17:00
    End of Course

Trainers

Additional Information

  • Call for Abstracts

    Download Call for Papers

    Call for Papers/Abstracts is available now.

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    Abstract Submission

    Call for Papers/Abstracts is available now.

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  • Learning Objectives

    Learning Objectives

  • Why Attend

    Why Attend

  • Who Should Attend

    Who Should Attend

  • 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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