Recorded Sessions at 2019 ISPE Aseptic Conference

The 2019 ISPE Aseptic Conference has ended but there is still a great opportunity to take advantage of the education sessions that took place during the conference by purchasing the recorded sessions package.  This package includes 6 education sessions totaling 8 hours of dynamic content. 

Sessions Includes

Day 1
18 March 2019
  • Opening Plenary Session
    0900 - 1015

    In this opening Keynote Session, Rick Friedman from FDA’s Office of Manufacturing Quality shares his perspective of the state of aseptic processing, providing insights on the very latest findings and learnings.

    The State of Aseptic Processing: Current Findings and Learnings

    Rick Friedman
    Deputy Director, Office of Manufacturing Quality
  • Preventing Cross Contamination in Shared Equipment/Facilities I
    1100 - 1230

    Regulatory and Occupational Safety as well as Cleaning and Cross Contamination requirements for aseptic toxic/high potent substances are covered during this session.

    Combined products like ADCs (Antibody Drug Conjugates) require PDE (Permitted Daily Exposure) of low nanograms per day level. This session will include strategies to avoid cross contamination in shared facilities and protect operators.

    • Presentation: GMP and Cleaning Requirements for Highly Potent Aseptic Products - New Annex 1 Impact
      By Richard Denk
    • The Value of Containment Technology: A Comprehensive Business Case for Driving Implementation
      By David Eherts, PhD, CIH
    • ADCs, High Potent Aseptic Filling
      By Wolfgang Lau, Dipl. Ing. and Hartmut Karl Schaz
    Richard Denk
    Senior Consultant Aseptic Processing & Containment
    Placeholder Person Graphic
    David Eherts, PhD, CIH
    VP Global EHS
    Wolfgang Lau, Dipl. Ing.
    Project Manager
    Roche Diagnostics GmbH
    Hartmut Karl Schaz
    Global Technology Partner
  • Preventing Cross Contamination in Shared Equipment/ Facilities II
    1330 - 1500

    According to industry projections, by 2025 every other new Biopharma Product will be considered a highly potent/toxic product. Smaller batches, personalized medicine, and a high demand to prevent cross contamination will be the challenges for aseptic processing in the future.

    This session will cover different case studies on high potent aseptic fill & finish. Modular and easy to change technologies from the view of a CMO will round out the session.

    • Case Study: Intro of Manufacturing Facilities for Highly Potent Lyophilization Sterile Products
      By Tomoharu Takeda and Ken Nagai
    • Using Virtual Reality to prevent cross-contamination in shared Equipment/ Facilities
      By Mikael Lecocq and Andre J. Zdunczyk
    • Automated Cleaning of Parts in HPAPI Production
      By Michael Kradolfer
    Placeholder Person Graphic
    Tomoharu Takeda
    General Manager,Technology Development
    Nagase Medicals Co Ltd
    Ken Nagai
    Manager, New Business Development
    Airex Co., Ltd
    Mikael Lecocq
    Director of Operation, Industrial Division
    Andre J. Zdunczyk
    Sales Manager
    Bausch + Stroebel Machine Company, Inc.
    Michael Kradolfer
    Head of Marketing & Product Management
    Belimed AG
  • Use of Robots in Aseptic Processing: Lessons Learned – the Perspective from Engineering Companies
    1545 - 1715

    This industry panel discussion session begins with short, five-minute presentations from leading engineering companies followed by a moderated discussion. The discussion centers around lessons learned and the future outlook of robotics in aseptic manufacturing major installation projects, retrofitting of existing lines, and possibilities and limits of the use of robots, and robots versus simple automation.

    Klaus Ullherr
    Senior Product Manager
    Syntegon Technology GmbH
    Paul F. Valerio
    Director of Process Technology / Senior Associate
    IPS - Integrated Project Services, LLC
    Hartmut Karl Schaz
    Global Technology Partner
    Norman A. Goldschmidt
    Genesis AEC
    Todd L. Vaughn
    Senior Regulatory and Design Specialist & Fill Finish SME
    Ian Kevin Owen
    Global Aseptic Fill Finish Subject Matter Expert
    Exyte Central Europe GmbH
    Jonathan Becker
    Sr. Project Manager
    RPA Engineering
Day 2
19 March 2019
  • Annex 1 Hot Topics
    0800 - 0900

    The European Medicines Agency (EMA) issued a draft version of Annex 1 for discussion in December 2017. As this guideline, once approved, applies to all manufacturing in Europe, as well as all PIC/S (Pharmaceutical Inspection Co-operation Scheme) countries and for all products imported to Europe, it has a huge impact on industry. ISPE, under Jean-Francois’ leadership, submitted consolidated industry comments to EMA.

    In this breakfast session, the hot topics from the draft Annex 1 and their implications for industry will be discussed. Examples include: contamination control strategy, post-sterilisation-pre-use-integrity testing of sterilizing filters and H2O2 decontamination processes.

    Jean-Francois Duliere
    Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
  • Preventing Cross Contamination in Shared Equipment/Facilities III
    1045 - 1215

    High Potent/Toxic aseptic processing and facility design is a very complex interaction between the equipment, room, airlocks, utilities, cleaning and waste handling. During this session Automated Solutions, Isolator Technology, and design challenges for a new oncology products facility will be presented.

    • Flexible Zero Loss Application in Isolator Technology for Oncology Therapies 
      By Matthias Beck, PhD and Uwe Harenberg, PE
    • Challenges of Selecting the Right Concept for a High Potent Aseptic Facility: from Material Dispensing to the Fill/Finished Product
      By Christian Mrotzek
    Matthias Beck, PhD
    Manager New Business Development
    Oncotec Pharma Produktion GmbH
    Uwe Harenberg, PE
    Managing Director
    Christian Mrotzek
    Sr. Director Technology Center
    Fresenius Kabi USA, LLC


Purchase Today

The recorded sessions package includes all 6 education sessions displayed above, totaling 8 hours of dynamic content.  

Member: US$349
Nonmember: US$399

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