STABILITY TESTING & PROGRAM MANAGEMENT EXCELLENCE

There are numerous Stability guidelines from ICH, FDA, WHO have surfaced many years; however, industry still has challenges to overcome to maintain compliance with current regulations. The time has never been more critical to evaluate your program, ensure your organization has an advanced, compliant processes and to learn about proposed changes to current stability guidelines and processes. This year, KENX is collaborating with Pharmalytik LLC to bring many well-known stability SMEs from prevalent pharma companies to share their experiences on program management and stability sciences.  KENX also is partnering with Pharmaceutical Stability Discussion Group (PSDG) to have multiple breakout sessions to discuss stability practices and industry trends.

Hear Stability Leaders Showcasing Best-In-Class Programs! Highlights Include:

• Key Learning to Set Up Stability Studies at CROs
• Mapping Stability Functions – Your Program in the Big Picture
• Compendial Resources to Support Modern Technologies, Including Physical Stability and Continuous Manufacturing
• Stability of Combination Products – How to Utilize Worst Case to Bracketing & Matrixing Study Designs
• Designing Phase-Appropriate Stability Program
• Developing Structured Process to Evaluate Data
• Revision of ICH Q1 (R2) Requirements – The Future of Stability Studies
• Evaluating the Performance of the Marketed Stability Program and Keeping It in Compliance
• Effectively Handling Stability Deviations and Investigations
• Conducting Shipping Studies to Support Product Distribution
• Establishing Stability Studies to Support Vaccines
• Applying and Mastering Stability Statistics
• Chamber Monitoring, Responding to Excursions, Best Maintenance Practices

PLUS! This event is co-located with Analytical Procedures and Methods Validation:

Analytical Methods and Procedures Validation Page HERE

Personnel in the Following Environments Should Attend:

Development and Manufacturing – (Bio)pharmaceutical, API and Medical Device

QA/QC

Stability Laboratories

Raw Materials

Laboratory Management

Regulatory Affairs

Formulation

This event is also appropriate to business development and sales managers that offer innovative solutions for QC testing laboratories, data collection, and statistics.