Hot Stability Topics

The 2022 PSDG Meeting takes place live and virtually on June 20-22 in Philadelphia as the Stability track within KENX’s Laboratory University. PSDG selects the presentation topics and breakout sessions, while KENX produces the conference. You provide the discussion, questions, and bench-marking polls.

Pre-Scheduled Topics

• Stability Deviations and Out of’s (OOS, OOT, OOE) Investigations
• The Modernization of the ICH Q1 Stability Standards
• Staples of, and Best Practices in Applying Stability Statistics
• Elements of Sample Control-Compliance, Inventory & Tracking
• FDA Perspective on GMP Pharmaceutical Laboratories and Stability Operations
• Stability Hall of Shame: Regulations, Guidelines & Expectations vs 483’s Warning Letters and Worse
• Setting and Evaluating the Performance of Specifications
• Validation of Stability Methods for Biological Products
• Stability Chambers Selection, Validation and Calibration
• Chamber Monitoring, Responding to Excursions, Best Maintenance Practices
• Mapping Stability Functions; Your Program in the Big Picture
• FDA Perspective on Qualification of Reference Standards
• Stability Reporting for Product Teams, Management, and Regulatory Stakeholders
• Developing a Stability Shelf Life Budget- Manufacturing and Shipping Challenges to Stability
• Developing a Stability Financial Budget – Predicting the future and how much it could cost

Breakout Sessions (attend 2 out of 6, but hear summaries from all):

• Contract Research Organizations
• Low Temp Products Stability
• Stability Stakeholder Optimization
• Laboratory Information Management Systems
• Device & Combination Products
• Forced Degradation/Extractables & Leachables

The Virtual Stability Facility Tour will allow you to take the tour virtually but interact with the tour hosts live.

See and hear the latest from suppliers of Stability equipment and services. In addition, attendees can cross over to either of the Analytical and Compliance tracks.

PSDG is excited to gather once again and learn from experts as well as each other, what’s happening in our operations, with our inspections, and in the evolving realm of guidances. We hope you can join us. To obtain more information about the program, contact John O’Neill at john@stabilityhub.com or to obtain information about pricing, registration, and hotel, contact Howard Wilensky at howard.wilensky@kenx.org.