2022 ISPE Aseptic Conference

Where Regulatory Guidance and Implementation Meet

Call for Proposals

Submission Deadline: 15 August 2021
Committee Review Begins: 15 August 2021
Notifications: 20 September 2021

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.

Proposals are requested for the following topics:

  • Advanced Therapy Medicinal Products (ATMPs) – Including Implementation of PIC/S Annex 2A
  • Annex 1: Implementation Strategies
  • Cleaning and Cross Contamination Control Strategies
  • Continuous Manufacturing for Sterile Products
  • Emerging Aseptic Technologies: Rapid Microbiological and Online Testing
  • Flexible and Multi-Product Facilities: Case Studies
  • Flexible small-scale manufacturing for development and clinical trials
  • High Potent Compounds, Containment and Sterility
  • Lessons from COVID-19: Supply Chain Issues, Operation Readiness, and Regulatory Challenges
  • New Robotics Applications in Aseptic Processing
  • Pharma 4.0/Digitalization/Data Integrity/AI in Sterile Manufacturing
  • Ramp-up of Vaccine Production to Address COVID-19: Case Studies
  • Recent RABS and Isolator Installations: Case Studies
  • Scale-out vs. scale-up for machinery
  • Single Use Technologies: Learnings from the Pandemic
  • Standardization vs. customization for machinery
  • Upgrades and Renovations of Aging Facilities: Case Studies

Submit Proposal


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.
Chair
Christa B. Myers
Senior Associate, Pharma Market Director
CRB
Co-Chair
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Alexander Haig
Vice President, Engineering
INCOG BioPharma Services, Inc.
Michael G. Higgins
Senior Compliance Advisor
Roche/Genentech
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
CAI