2023 ISPE Aseptic Conference

Featured Speakers


Conference Overview

The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies - new, targeted approaches to treatment resulting in small-batch aseptic products - are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.

Thus, as we slowly navigate to the post-COVID world and return to the new normal, ISPE’s Aseptic Conference wants to realign our focus. We welcome you to participate at the 2023 ISPE Aseptic Conference to learn and share progress, success stories, best practices and lessons learned. See you in North Bethesda, Maryland!

Featured Topics

  • Annex 1 Solutions and Implementation
  • Robotics and Digitalization
  • Manufacturing Case Studies
  • Process Control and Quality Risk Management
  • Contamination Control in Aseptic Processing
  • Decontamination and Single-use Systems
  • Improvements and New Technologies in Aseptic Manufacturing
  • Microbiology, Cleaning, and Training

Keynote Presentations

Monday, 6 March 2023

Tuesday, 7 March 2023

What to Expect

Watch some of the 2023 ISPE Aseptic Conference highlights to get a taste of how you'll benefit from compelling discussions and knowledge exchange opportunities on the latest advancements in pharmaceutical manufacturing facilities.

Overview:

  • 7.5+ hours of dedicated networking time.
  • 11.5+ hours of dedicated education sessions & learning opportunities.
  • 5+ hours of additional sessions available on-demand after the conference. 16.5+ hours total of education from all conference sessions.
  • Expansive Expo Hall.
  • Expo Hall giveaways & engagements.
  • Growth opportunities for Students and Emerging leaders.
  • 90-minute concurrent sessions with audience interaction.
  • Conveniently located in North Bethesda, Maryland.
  • One-day Expo Pass for $75.
  • Unique perspectives from both industry and regulatory speakers to obtain a wholistic understanding of the trends and issues impacting the Sterile Manufacturing practices.

Sunday:

  • Introductory/101 session to discuss: ISPE, Regulation, Aseptic Processing and more!
    • All attendees are welcome, but this session is tailored more specifically to students, emerging leaders, young professionals, first time attendees, or those needing additional insight into all things Aseptic!

Monday:

  • Conference kick-off
  • Morning Keynote by Brooke Higgins
  • AM Concurrent Sessions
  • PM Concurrent Session
  • Industry Panel (75 mins.)
  • Networking Reception

Tuesday:

  • Women in Pharma® Sponsored Breakfast Session
  • Morning Keynote by Emily Craven
  • AM Concurrent Sessions
  • PM Workshop
  • Expo Hall Giveaway Drawing
  • Industry Panel (75 mins.)

Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Chair
Francesco Cicirello
Director, Quality Assurance
Evelo Biosciences
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Alexander Haig
Vice President, Engineering
INCOG BioPharma Services, Inc.
Michael G. Higgins
Sr. Director External Engagement and Supplier Quality
Moderna Therapeutics
Chervee Ho, Head of Asia Pacific
Director of Business Development & Key Account Management, Asia Pacific
Vetter Pharma
Ryan Paul Mazur
Process Engineer
Genesis
Christa B. Myers
Aseptic and Sterile Products Market Director
CRB
Co-Chair
Nidhi C. Shah
Director Aseptic Processing SME
Sanofi Pasteur – Swiftwater
Klaus Ullherr
Senior Product Manager
Syntegon Technology GmbH
Keith W. Weseli, CPIP
Commissioning and Qualification Project Director
Stevanato Group