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Follow on Google News | Full day Virtual Seminar on Pharmaceutical Stability - Webinar By ComplianceOnlineThis 6 hour webinar on Pharmaceutical Stability will include a detailed overview of regulatory requirements for Stability Programs, how to design one and report the data in regulatory filings and supporting cGMP systems for a Stability Program.
By: ComplianceOnline 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. # # # Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates. End
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