Program Overview
This program provides intermediate-level insights into Stability Operations for drugs, biologics, and medical devices. Participants will explore key topics such as designing phase-appropriate stability protocols, managing stability studies, and addressing common challenges like chamber excursions and sample control. The course also covers the importance of financial and resource planning, stability lifecycle budgeting, and creating stability reports for stakeholders. Leveraging Laboratory Information Management Systems (LIMS) for efficient data management and regulatory compliance will also be explored in detail. Delivered by an industry expert with 25+ years of experience, this program emphasizes practical, real-world applications and offers hands-on exercises to help participants solve actual stability-related problems.
Features
- Design and manage phase-appropriate stability protocols for drugs, biologics, and medical devices.
- Implement effective strategies for managing stability studies and ensuring compliance with global regulatory standards.
- Leverage Laboratory Information Management Systems (LIMS) for optimal data tracking and reporting.
- Address stability challenges, including chamber excursions and sample control, with actionable solutions.
Target audiences
- Professionals in the pharmaceutical, biotech, and medical device industries, particularly those in R&D, Quality Assurance, Regulatory Affairs, and Operations.
Instructor
