Education Details
Honorary Chair
Charlotte Enghave Fruergaard, PhD, Director of Technology, NNE
Pharmaplan
2013 Chair of the ISPE International Board of Directors
Keynote Presentation
Rick
Friedman, Rick Friedman, Associate Director, OMPQ, FDA
FDA Perspectives on Aseptic Processing
Learn the latest notable trends and findings in aseptic processing and discuss opportunities for
modernization and risk mitigation that will provide higher assurance of sterility in aseptic operations.
Barrier ♦ Aseptic ♦ Sterilization ♦ Regulatory
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Barrier Isolation and Containment
Leaders:
- Ryan Hawkins, Vice President Operations, Cook Pharmica, USA
- Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
Download the Agenda ( 52 KB)
This track is the continuation of the stand alone Barrier Isolator Conference. It will focus on the use of RABS and Isolators for aseptic processing and also incorporate containment applications.Technology updates, case studies and discussion groups will be used to discuss the latest issues with advanced aseptic processing.
Learning Objectives:
- Learn Technology updates from global industry vendors
- Learn from RABS and Isolator case studies from users who have been there
- Participate in discussion groups to answer your questions
- Answer your regulatory questions with FDA Q&A
At the conclusion of the session participants will be able to:
- Understand the new developments in process equipment
- Learn from those who have walked the path with case studies on advanced aseptic processing
- Participate in discussion groups of hot topics for advanced aseptic processing
- Exchange information and get regulatory perspective from interactive Q&A session
Speakers:
- Michael Byron, Project Manager, Seiberling Associates Inc, USA
- Sean Christian, Manufacturing Manager, Revalesio Corporation, USA
- Edward Connolly, Chief Operating Officer, Pharmalucence, Inc., USA
- Donald Eddington, PhD, Director of R&D, METALL + PLASTIC, USA
- Aidan Harrington, PhD, Senior Project Manager, DPS Engineering & Construction Ltd, Ireland
- Thomas Huber, Dipl. Ing Eth, Sales Dir.-Deputy To CEO, Skan AG, Switzerland
- Koji Kawasaki, President, Airex Co Ltd, Japan
- Patrick Poisson, SVP Mfg, Sterile Products, United Therapeutics, USA
- James Rickloff, Scientific Director, Sterilization Technology Group, USA
- Chad Schrader, Process Engineer, Revalesio Corporation, USA
Aseptic
Leader:
- Joerg Zimmermann, Director Process Development and Implementation, Vetter Pharma Fertigung GmbH & Co. KG, Germany
Download the Agenda ( 52 KB)
This track is looking at advances in aseptic processing and in particular into disposables. There will be a broad range of topics which are important to aseptic processing, from compounding, fill-finish, lyophilisation, components etc. The use of disposables has been promoted a lot recently, but do they deliver what they propose? We will take a look at that at various steps in the production chain.
Learning Objectives:
- Learn about the latest developments in aseptic processing
- Hear about new trends and novel concepts in unit operations
- Learn about the opportunities and limitations of disposable technologies
At the conclusion of the session participants will be able to:
- Attendees will have learned about trends in aseptic processing and disposable technology.
- Attendees will be able to revisit their own processes with these new ideas
- Attendees will be able to potentially implement new ideas or modify their processes to meet current and coming standards
Speakers:
- Sam Da Costa, Novalabs, United Kingdom
- Frank DeMarco, Manager Freeze Dryer Dev, IMA Life North America, USA
- Angelika Freitag, PhD, Project Leader, Coriolis Pharma Research GmbH, Germany
- Timothy Hanrahan, Advanced Aseptic Technology Expert, Rye Pharma Inc., USA
- Carl Hitscherich, PhD, New Product Lead, Biogen IDEC, USA
- Eric Isberg, Global Product Manager, ATMI, USA
- Mathias Kreher, Product Manager, Robert Bosch GmbH, Germany
- Christine Martin, PhD, Head of Warehouse, Compliance and Visual Inspection, AbbVie Deutschland GmbH & Co. KG, Germany
- Michael Moussourakis, Marketing Manager, Pall Life Sciences, USA
- Claudia Roth, PhD, President, Vetter Development Services USA, Inc, USA
- Robert Roy, PE, Director Aseptic Technology, IPS, USA
Cleaning and Sterilization
Leaders:
- Rebecca Brewer, Dir, Validation & GMP Comp, Dober Group, USA
- Gordon Leichter, PhD, Regional Sales Manager, Belimed, Inc., USA
Download the Agenda ( 52 KB)
Case studies and technology updates will be presented at the Sterilization and Cleaning Track, ensuring that you are apprised of the state of the industry in these two fundamental programs for aseptic processing.
- See first-hand how state-of-the-industry sterilization programs are established, controlled and monitored to limit risk
- Understand how to develop scientific rationales for product families in cleaning and for hold time studies in both cleaning and sterilization to minimize validation effort
- Learn how Design Space is being utilized in both cleaning and sterilization
At the conclusion of the session participants will be able to:
- Develop sound risk mitigation plans for their cleaning and sterilization programs
- Take-away critical success factors, and lessons learned, from successfully managed cleaning and sterilization programs
- Address today’s regulator’s concerns as well as ensure patient safety in every aspect of design, validation, control and management of cleaning and sterilization programs
Speakers:
- Jerry Dalfors, Principal, JD Technologies LLC, USA
- Jeffrey Ditmore, Project Manager, Valsource, USA
- Evan Goulet, PhD, Technical Application Manager, Noxilizer, Inc., USA
- Carl Hospach, Sr. Project/Process Engineer, Merck & Co Inc, USA
- Laura Klewer, Senior Engineer, Amgen Inc, USA
- John Logar, Director Radiation Sterilization, Johnson & Johnson, USA
- Christopher Moore, Manager, DS Process Sciences, Fujifilm Diosynth Biotechnologies Inc, USA
- Thomas Ofenböck, Sales Manager, BOSCH, USA
- John Spohn, CPIP, Sr. Project Mgr, New England Operations, Hargrove Life Sciences, USA
- Sumit Verma, Focus Factory Manager for Reactor Hot Products, Nuclear Imaging Division for Covidien Healthcare, USA
Regulatory Involvement
Regulatory Panel Discussion with Audience Q&A:
- Rick Friedman, Associate Director, OMPQ, FDA, USA, Confirmed
- Destry Sillivan, Senior Regulatory Review Officer, FDA, USA, Confirmed
- Robert Sausville, Director, Division of Case Management (DCM) Office of Compliance and Biologics Quality, at FDA’s Center for Biologics Evaluation and Research, FDA, USA, Confirmed
- Dave Doleski, Acting Director, Division of Good Manufacturing Practice Assessment, OMPQ, OC, CDER, USA, Confirmed
- Tara Gooen, Senior Regulatory Operations Officer, FDA, USA, Invited
- Thomas J. Arista, Field Investigator, National Expert Pharmaceutical/Biotechnology, Office of Regulatory Affairs, Drug Inspection Branch, FDA, USA, Invited
At the conclusion of the session participants will be able to:
- Develop sound risk mitigation plans for their cleaning and sterilization programs
- Take-away critical success factors, and lessons learned, from successfully managed cleaning and sterilization programs
- Address today’s regulator’s concerns as well as ensure patient safety in every aspect of design, validation, control and management of cleaning and sterilization programs
- Conference Brochure ( 1 MB)
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