Skip To The Main Content
2019 TC-SUS_1988x680

Single-Use-Systems – A New Age of Drug Making

Nov 26 - Nov 27, 2019
Göttingen, Germany

  • Education
  • Europe

left to register

Program Highlights
This course will take place at the Sartorius Stedim facilities in Göttingen.

Overview

In the biomanufacturing world, a huge diversification of products takes place with new therapeutic approaches rising up. Novartis e.g. recently released a new gene therapy drug for two Million Euros per dose, while other companies are still in the development phase for drugs targeting the same disease. Wouldn’t it be great for them to have released these drugs faster to be the first one and to make two Million Euros per dose themselves? And what technologies might have helped to reach this goal?

One possibility to get drugs faster to the market is the use of single-use systems. But are they robust enough, when the product contact layer is made from polymers? And what will the authorities say? If the equation SUS plus GMP results in SOS to you, then you should sign up to this two-day course. Here you will learn and discuss with technical trainers and specialists for data handling and GMP regulations how to implement and operate single-use technologies in a GMP-controlled environment.

During an optional third day you can have a look into the manufacturing of single-use bioreactor bags and filters, followed by a visit in the Sartorius Application Center where you can see and test complete process solutions from molecule discovery to large scale biomanufacturing.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, 26 November 2019

    9:00
    Welcome & Introduction of Participants


    9:30
    Introduction to Single-use Bioprocessing


    10:00
    GMP Update on SUS (Part 1)

    • Current GMP regulation
    • FDA requirements
    • Technical guidelines
    • Regulatory expectations

    10:45
    Coffee Break

    11:00
    Hands-on Exercise 1

    • Gowning
    • Experiment on advantages of SUS

    12:30
    Lunch Break

    13:30
    GMP Update on SUS (Part 2)

    • New Annex 1 requirements

    14:00
    Basics in Single-use Bioprocessing

    • Manufacturing of SU Consumables
    • Different bag functionalities
    • Connection/disconnection technologies

    14:45
    Coffee Break

    15:00
    Hand-on Exercise 2 (Cleanroom)

    • Bag handling (Storage and mixing bags)
    • Connection/Disconnection

    17:00
    Wrap-up Day 1


    17:15
    End of Day 1

  • Wednesday, 27 November 2019

    8:30
    Sensors and Automation in Single-use Systems

    • Overview and demonstration

    9:15
    Data Integrity, Data Analysis and Monitoring

    • Regulatory requirements and guidelines
    • ALCOA
    • Data Integrity for computer, paper and hybrid systems
    • Control of meta-data
    • Data integrity strategies for compliance
    • Checking for Data Integrity issues in practice
    • Experimental approach

    10:15
    Coffee Break

    10:30
    GMP View on Media Preparation

    • GMP requirements
    • Best practice in equipment and facility design

    11:15
    Filtration & CCIT

    • Filter integrity testing
    • CCIT for SUS
    • GMP considerations

    12:15
    Lunch Break

    13:15
    Hand-on Exercise 3

    • Media preparation
    • Filter Integrity testing

    15:00
    Coffee Break

    15:15
    Data Recording & Evaluation

    • Data logging
    • Batch monitoring

    15:45
    Filter Integrity Testing Fault Handling – GMP View

    • GMP requirements
    • Pre- and Post-use integrity testing
    • Impact of new EU GMP Annex 1 requirements

    16:00
    Wrap-up Day


    16:30
    End of Course

  • Thursday, 28 November 2019 - Optional Facility Tour

    8:30
    Insight Into the Production of Bag Assemblies

    • Injection molding of components (e.g. connectors, filter housings, etc.)
    • Production of 50 and 200 L bags for SU bioreactors (STR)

    9:30
    Insight Into the Production of Filters

    • Membrane production
    • Cartridge, capsule and filter modules production

    11:00
    Coffee Break

    11:15
    Overview on Complete Single-use Bioprocesses From Molecule Development to Final Filling

    • Tour through the Application Center
    • With option for further hands-on tests

    13:00 - 14:00
    Farewell Lunch

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the training course the participants

    • have understood the regulations and relevant guidelines for single-use system (SUS) handling
    • can explain basics in single-use processing, bag functionalities, connection-disconnection technologies
    • can operate bags, tubings, filters and sensors
    • have understood Data Integrity and Data Analysis / Monitoring for SUS handling
    • have understood possible setups for filter and container closure integrity testing in single-use assemblies
  • Who Should Attend

    Who Should Attend

    • Operators
    • Manufacturing Supervisors
    • QA Managers
    • Manufacturing Managers
    • QC Managers
    • Auditors
  • 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.

Got a Question? We have answers

Contact Us

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.

Sartorius Stedim Biotech

Otto-Brenner Str. 20
Göttingen, Germany

  • Accommodations

    Hotel Nearby

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

    Best Western Hotel Am Papenberg
    Hermann-Rein-Straße 2, 37075 Goettingen
    Tel: +49 551 30550

  • Amenities

How to Get Here

By Air

Nearest Airport: Hannover Airport
Airport Phone:
+49 (0)511 977-0

By Car

More information coming soon.

Other Options

More information coming soon.

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 [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.

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially