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2019 Virus Filtration

All About Virus Filtration - A Practical Approach

Sep 10 - Sep 11, 2019
Cologne, Germany

This training course about virus filtration will provide the attendees with a profound understanding about the current state of the art around this topic.

  • Education
  • Europe

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Program Highlights
This Course will be held at the Asahi Kasei Medical Facility in Cologne.

Overview

This training course about virus filtration will provide the attendees with a profound understanding about the current state of the art around this topic. A thorough introduction to virus filtration will be given as well as in-depth background and a mechanistic understanding about the principles of (parvo-) virus retention will be available to the attendees at the end of the course. An interactive session will address the question of “how to design an efficient virus filtration process?” and a practical session will provide some hands-on experiencewith lab- and production-scale virus filter modules.

Agenda

  • Day 1
  • Day 2
  • Tuesday, 10 September 2019

    8:30
    Welcome and Theory 1

    • Introduction into eukaryotic DS manufacturing process
    • Virus Filters in biopharmaceutical manufacturing
    • Sources of virus load
    • Reason/necessity for virus removal from DS
    • Brief overview of guidelines
    • Methods for virus removal

    10:00
    Coffee Break

    10:30
    Hands-on 1: Set-up and Handling of Filters

    • Set-up in lab-scale: hands-on
    • Display of production scale filters
    • Integrity tests: hands-on
    • Demonstration of integrity test automation

    12:30
    Lunch Break

    13:30
    Theory 2: Case Study

    • Up- & Downscaling of a virus filtration step

    15:00
    Coffee Break

    11:00
    Interactive Session:
    Designing a virus filtration process – assumption and points to consider

    • How to design a process
    • Calculating production costs

    17:00
    End of Day 1

    18:00
    Networking Dinner

    Wednesday, 19 September 2019

    8:30
    Wrap-up Day 1


    9:00
    Theory 4:

    • Mechanistic principles of (Parvo-) Virus retention
    • Virus filters as bioprocess subject – current hot topics (ATMPS, facility segregation, etc.)
    • Challenges of implementing virus filtration into continuous manufacturing

    10:30
    Coffee Break


    11:00
    Theory 5:

    • How to organize a virus clearance study
    • Challenges in VC studies
    • Historical data
    • Case studies for VC studies

    12:30
    Lunch Break


    13:30
    Interactive session:
    Pitfalls in the development of a virus filtration process

    • Bring your own case/topic/question/problem/challenge for discussion!

    15:00
    Wrap-up, Q&A


    15:30
    End of Course
  • Wednesday, 19 September 2019

    8:30
    Wrap-up Day 1


    9:00
    Theory 4:

    • Mechanistic principles of (Parvo-) Virus retention
    • Virus filters as bioprocess subject – current hot topics (ATMPS, facility segregation, etc.)
    • Challenges of implementing virus filtration into continuous manufacturing

    10:30
    Coffee Break


    11:00
    Theory 5:

    • How to organize a virus clearance study
    • Challenges in VC studies
    • Historical data
    • Case studies for VC studies

    12:30
    Lunch Break


    13:30
    Interactive session:
    Pitfalls in the development of a virus filtration process

    • Bring your own case/topic/question/problem/challenge for discussion!

    15:00
    Wrap-up, Q&A


    15:30
    End of Course

Trainers

Andy Bailey
Andy Bailey
ViruSure GmbH
Michael Lasse
Michael Lasse
Charles River Biologics Testing Solutions
Franz Nothelfer
Franz Nothelfer
Consultant
Sebastian B. Teitz
Sebastian B. Teitz
ASAHI Kasei Bioprocess Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course the participant

    • have understood virus filtration principles
    • ability to set-up and handle virus filtration processes
    • have an overview of filter types and material
    • have understood challenges of different matrices
    • have gained hands-on experience with virus filters / process
      set-ups
    • have understood principles/requirements of filter integrity
      testing
    • have an overview of current guidelines and regulations
  • Who Should Attend

    Who Should Attend

    • R&D scientists
    • Supervisors in manufacturing
    • QA Manager (Regulatory Affairs, Pathogen Safety)
  • 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.

Asahi Kasei Medical

Gottfried-Hagen-Strasse 20
Cologne, Germany

  • Accommodations

    Training Location

    Asahi Kasei Medical
    Gottfried-Hagen-Strasse 20
    51105 Cologne
    Germany


    Hotels Nearby

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

    Leonardo Hotel Köln
    Waldecker Str. 11-15
    51065 Cologne
    Tel.: +49 (0)221 - 670 90
    Email
    Hotel Website
    Price per Room and Night upon Request
    Distance to the venue: 2. 1 km (7 min by the car)


    Pullman Hotel Cologne
    Helenenstraße 14
    50667 Cologne
    Tel.: +49 (0)221- 2750
    Hotel Website
    Price per Room and Night upon Request
    Distance to the venue: 6. 3 km (19 min by the car)

  • Amenities

How to Get Here

By Air

Nearest Airport: Cologne Bonn Airport - CGN
Airport Phone:
+49 (0)2203 40-4001

By Car

11.2 km, 10 min by car. Asahi Kasei Medical is at Gottfried-Hagen-Strasse 20, 51105 Cologne.

Other Options

Public transportation: 12 min by S19 Düren.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

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

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registration@pda.org

 

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