Why Should You Attend: This highly interactive course will include detailed discussions of current regulatory expectations and is therefore suitable for individuals new to the pharmaceutical industry and also serves as a refresher course for others.
This webinar will provide the attendee with a step-by-step foundation for determining product shelf life through stability testing. This comprehensive training course outlines the issues and guidelines surrounding FDA, ICH and increasing important Global regulatory requirements. In the second section, the course will address a all the steps in a stability program starting from designing an effective stability program to preparing a Stability Report and understanding how to report the data in Regulatory filings.
The last part of the webinar will focus on supporting cGMP systems, including Qualification and Maintenance of Stability Chambers, choosing the right Analytical Methods and handling Out of Specification results during Stabilty Studies. Sample 483s are reviewed to better understand typical deficiencies and how to avoid them.
Duration: 6 hours of instruction, one hour lunch, 15 min breaks as they fit into the schedule.
Agenda: Eastern Standard Time - 10:00 AM to 12:00 PM : Introductory Concepts and Regulatory Requirements.
- 12:00 PM to 01:00 PM : Lunch
- 01:00 PM to 03:00 PM : Stability study from start to finish.
- 03:00 PM to 03:15 PM : Break
- 03:15 PM to 05:15 PM : cGMPs for a Stability Program - from Tox Phase to Commercial Phase.
- 05:15 PM : Final Q&A Session
