2022 ISPE Aseptic Conference: Where Regulatory Guidance & Implementation Meet

Register now for the 2022 ISPE Aseptic Conference, the #1 event for aseptic and barrier professionals that has been setting the pace for over 30 years. Join us in North Bethesda, MD from 14–15 March 2022 to hear the latest in regulatory practices directly from regulators, new strategies in robotics, overcoming challenges in C+G/ATMPs, and more!

Case studies, interactive group discussions, and regulatory insights are the benchmarks of this signature conference.

Breakout sessions and panel discussions will feature industry case studies and lessons learned on:

• 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, ATMPs, 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

Confirmed Featured Speakers:

• 

  Robert Sausville
  

  Director, Division of Case Management

  FDA/CBER/OMPT/OCBQ
• 

  Joyce M. Hansen
  

  Vice President of J&J Microbiological Quality and Sterility Assurance

  Johnson & Johnson
• 

  Paul A. Gustafson
  

  2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor

  Regulatory Operations and Enforcement Branch (ROEB), Health Canada
• 

  Alonza Cruse
  

  Director, Office of Pharmaceutical Quality Operations

  FDA/ORA
• 

  Rick Friedman
  

  Deputy Director, Office of Manufacturing Quality

  CDER/FDA
• 

  Brooke Higgins
  

  Senior Policy Advisor for the Global Compliance Branch 3

  FDA

Can't make it to North Bethesda? Secure the Virtual All Access Pass and enjoy the event from the comfort of your home or office.

Explore Agenda & Register