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2019 ParPack

Container Closure Development - Spring Edition

Mar 21, 2019
Venice, Italy

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, 21 March 2019

    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

Jörg Zürcher
Jörg Zürcher
Bayer HealthCare

Additional Information

  • Learning Objectives

    Learning Objectives

    • Set-up of a target product profile of a container closure system
    • Select appropriate container closure materials, components, and systems
    • Apply the appropriate regulations and standards to container closure systems for parenteral formulations
    • Prepare a development plan of a container closure systems from the early development until market phase
    • Specify container closure system regarding technical aspects and regulatory requirements
    • Understand compendial requirements and quality as well as technical standards regarding container closure components and systems
  • Who Should Attend

    Who Should Attend

    • Scientists in Drug Product Development
    • Scientists/ Engineers in Packaging Development
    • Regulatory Affairs Experts
  • 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 €895

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 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
  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship

    gomez@pda.org

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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