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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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