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2020 ParPack

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.

Overview

More information coming soon.

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

      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.

    Wilco AG

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

    Wilco AG
    • Accommodations

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


      Pullman Basel Europe
      Clarastrasse 43
      4058 Basel
      Switzerland
      Tel: +41616908080

      The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

      The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.


      Swissôtel Basel
      Messeplatz 25
      4005 Basel
      Switzerland
      Telephone : +41 61 555 3333
      [email protected]

      The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centres are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

      It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

      The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    • Amenities

    How to Get Here

    By Air

    Pullman Basel Europe:

    Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.


    Swissôtel Basel

    Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the hotel.

    By Car

    Swissôtel Basel

    Exit ‘Basel Nord/Kleinhüningen’ from Hwy A5 or exit ‘Badischer Bahnhof/Basel Ost’ from Hwy A35. Self-parking or valet parking is available at the car park of the fairgrounds (allowed maximum height of 2m).

    Other Options

    Pullman Basel Europe
    Rail:

    • The main train station ‘SBB Basel’ is approximately 2km away: take the tram No. 16 Bhfeingang Gundeldingen to Clarastrasse (duration 15-17 minutes, departure every X minutes)
    • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram No. 6 or No. 16 to Clarastrasse (duration 4 minutes, departure every 8 minutes)

    Swissôtel Basel
    Rail:

    • The main train station ‘SBB Basel’ is approximately 2km away: take the tram Nr. 1 or Nr. 2 to Messeplatz Basel
    • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram Nr. 6 to Messeplatz Basel

    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.

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

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