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Agenda

Our agenda is carefully curated to provide diverse viewpoints, scientific exchange, and a forum to share challenges. We’ll focus on industry trends; share research insights; explore and exchange technologies, strategies, and capabilities; provide training opportunities; and create rich opportunities for learning and connection between people and organizations.
Day 1

Registration and Continental Breakfast

Welcome and Opening Comments

Session 1 – Recognizing and Identifying Hazards

  • Elements of a Successful Potent Compound Safety Program
  • Types of Hazard Evaluation and the History of Occupational Exposure Banding
  • Hazard Evaluation of New Chemical Entities (Drug Innovator Perspective)
  • On-boarding of New Chemical Entities (CDMO Perspective)
  • Integrating New Modalities into Existing Banding Systems
  • Panel Discussion

Lunch

Session 2 – Evaluating Facilities, Equipment, and Risk

  • Aligning Operational Needs with EHS Needs
  • Designing a New Potent Compound Facility – Considerations for a Design Criteria Document
  • Renovating an Existing Facility to Handle Potent Compounds
  • Design Considerations for Exposure Control in Aseptic Facilities
  • Panel Discussion – Facility Design
  • How Clean is Clean?  Patient Safety vs Occupational Safety or Using IH Data to Support Cross-Contamination Issues

Day 1 Wrap-up

Reception

Day 2

Continental Breakfast

Session 3 – Controlling and Managing Exposure

  • ISPE Containment Guide
  • Ventilation Controls – Effectiveness, Design, and Applications
  • Integrating Process Equipment with Exposure Controls
  • Rigid-wall Isolator Design and Use
  • Flexible-wall Isolator Design and Use
  • Vacuum Transfer – Current Available Technologies
  • Aseptic Filling and Lyophilization – Challenges and Solutions

Lunch

Session 4 – Verifying Control and Continuous Improvement

  • ISPE SMEPAC Guidline Version 3 – What’s New?
  • Interpreting Containment Performance Assessment Results
  • Hands-on Experiential Learning Techniques

Day 2 Wrap-up

Adjourn

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