2022 ISPE Aseptic Conference

Where Regulatory Guidance and Implementation Meet

The impact of the global pandemic has been felt throughout the pharmaceutical industry and has altered the way we manage everything from operation readiness and supply chain issues to regulatory inspections. Sterile manufacturing practices and strategies are no exception. Benefitting from those lessons learned and preparing to implement new strategies for the future will be the focus of the 2022 ISPE Aseptic Conference.

Conference Sessions

  • Plenary Session: Regulatory Presentations from FDA and PIC/S
  • Plenary Session: Sterility Assurance Update and Cultivating Emerging Leaders
  • Industry Panel: Overcoming the Biggest Challenges in C+G/ATMPs
  • Regulatory Panel: FDA, Health Canada and many others!
  • Group Breakout Discussions: Aseptic, Barrier, Containment
  • Concurrent Sessions:
    • Implementation of New Robotics Strategies
    • Robotics Applications in Aseptic Filling Processing
    • Design & Development of Components in Aseptic Manufacturing
    • Upholding the Quality of Contamination Control Strategies from Design to Implementation
    • Trends in Aseptic Processing Applications: Impacts of COVID, ATMP, Supply Chain and More
    • Projects during the Pandemic--Technical and Process Case Studies
    • Process Development and Manufacturing for Highly Potent Substances
    • The Use of Enzyme H2O2-Indicators in Aseptic Production Environment

Featured Speakers

Who Should Attend

  • Aseptic manufacturing professionals and management
  • Aseptic processing consultants and global regulatory inspectors
  • Compounding pharmacy and small-scale facilities professionals
  • Continuous Manufacturing professionals
  • Design, facilities, building, commissioning, validation professionals
  • Engineering system owners or project managers responsible for aseptic processing equipment
  • Equipment manufacturers and suppliers providing state-of-the-art aseptic technology including robotics
  • Industrial Hygienists and Safety Personnel
  • Plant managers
  • Professional new to aseptic processing operations
  • Professionals new to Aseptic processing and product protection
  • Project managers
  • Quality Assurance personnel responsible for cleaning and prevention of cross contamination
  • Quality Assurance personnel responsible for maintaining the integrity of aseptic systems
  • Quality Systems/Assurance and Quality Control (QA/QC) including microbiology professionals
  • Research &Development professionals
  • Sterile Products Processing Community of Practice
  • Supply chain managers
  • Validation personnel responsible for aseptic processing equipment qualification

Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Christa B. Myers
Senior Associate, Aseptic & Sterile Market Director
Richard Denk
Senior Consultant Aseptic Processing & Containment
Alexander Haig
Vice President, Engineering
INCOG BioPharma Services, Inc.
Michael G. Higgins
Senior Compliance Advisor
Dina Manfredi
Director of Sales and Business Development
GMP Systems Inc
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Keith W. Weseli, CPIP
Director of Operations, Midwest Region

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