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Stability Statistics Overview Webinar
October 20, 2022 @ 11:00 am - 12:00 pm
Whether analytical, mechanical or electronic, all Stability statistics start life in a Stability Chamber. Tune in to our 60 minute webinar to discover what to do with the variety of data that comes across a Stability Stakeholder’s desk.
This event is sponsored by H&A Scientific.
Goals
- Be aware of all data reaching the desk of the Stability Stakeholder
- Know the pathway each category of data should take
- Explore the pitfalls and black holes awaiting your numbers
- Become familiar with your stakeholder friends who will help you tell your story statistically
- Learn the types of tools available to process your numbers
- Tailor your statistics story to your target audience
Who should attend
- Stability Group Members
- Quality Assurance
- Regulatory Affairs
- Statisticians new to the Stability process
- HVAC/Facilities stewards who want to grasp the significance of stability chambers
Agenda
- Welcome and Panel Introductions by KENX Moderator
- Overview of Webinar premise John O’Neill
- The rest is an interaction among discussion leader, panel members and participants
- Data about and from Stability Chambers
- Validation, Calibration, PMs, Monitoring, Excursions, Chamber Trending
- What are the Data processing regulations?
- Data by Protocol Design; meeting statistical needs (Know what stories you wish to tell)
- Data from the Study: How is the manufacturing holding up? How is the Package, Excipients, desiccants, etc. contributing? What is the projected/confirmed shelf life?
- Data from anomalies? Investigations of OOS, OOT, OOE
- How does raw data go to submitted registration data?
- What are the enemies of your statistical story?
- Who are your data processing friends?
- What are your data processing tools?
- Where can we go for further information?
- Any additional questions/ panel contact information
