ICH Q9 focused Revision Q9 (R1): Poster Presented at PDA Week 2026

Area of Science:

• Pharmaceutical Quality Management
• Regulatory Compliance Strategy
• Medical Device Quality Assurance

Background:

• A strong quality strategy is vital for pharmaceutical and device companies to meet strategic goals.
• Understanding quality risks and gaps early is key for regulatory approval, partner diligence, and audits.
• The product development lifecycle necessitates proactive quality management.

Purpose of the Study:

• To present a unique strategic quality plan model.
• To integrate Quality Risk Management (QRM) and Quality Management Maturity (QMM) with the FDA Six-Systems model.
• To provide a framework for identifying and prioritizing quality improvement efforts.

Main Methods:

• Combining Quality Risk Management (QRM) and Quality Management Maturity (QMM) concepts.
• Utilizing the FDA Six-Systems model as a foundational framework.
• Considering organizational and strategic context in risk identification and mitigation.

Main Results:

• Development of a strategic quality plan tailored to company objectives.
• Identification and prioritization of improvement efforts for compliance and efficiency.
• Creation of a holistic action plan addressing technical, structural, and behavioral deficiencies.

Conclusions:

• The integrated model offers a unique, strategic approach to quality management.
• This model supports compliance with US, EU, and global regulatory expectations.
• It ensures a compliant and efficient approach to quality throughout the product lifecycle.