CAGES℠
Structured Validation Training
CAGES Training: Structuring Validation for Compliance and Efficiency
At Brayearst Validation Consulting, we understand that process validation is the cornerstone of compliance in FDA-regulated industries. That’s why we’ve developed CAGES℠—a comprehensive framework designed to guide professionals through the intricacies of validation with clarity and precision.
CAGES℠ stands for Claims, Approach, Gathering Evidence, and Summary, offering a systematic structure to streamline validation efforts while ensuring regulatory compliance.
What You’ll Learn in CAGES Training
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Claims
Establish a shared understanding of process claims to align team objectives.
Define control set points and identify noise variables for process robustness.
Gain insight into daily monitoring and intervention strategies to maintain quality.
Recognize and prioritize regulated product characteristics critical for compliance.
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Approach
Develop a clear validation approach tailored to your processes and products.
Integrate company policies and procedures seamlessly into validation activities.
Address sampling, measurement, and acceptance criteria specific to your product’s needs.
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Gathering Evidence
Create robust instructions, data sheets, and execution plans for validation studies.
Analyze results effectively to ensure alignment with predefined claims and approaches.
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Summary
Organize validation documentation to facilitate reviews and audits.
Prepare for inspection and reference purposes with clear, concise records.
Build systems to ensure accessibility for future troubleshooting and process changes.
Why Choose CAGES℠ Training?
Why Choose CAGES℠ Training?
Our training programs are built on industry best practices and Six Sigma methodologies, tailored specifically for the life sciences sector. Whether you’re a professional in pharmaceuticals, medical devices, or biotech, CAGES provides you with:
Structured Guidance: Simplify complex validation processes.
Regulatory Focus: Ensure alignment with FDA and global compliance standards.
Practical Tools: Gain actionable strategies to enhance validation efficiency.
Training Options
We offer flexible training formats to meet your needs:
In-Person Workshops: Interactive sessions with hands-on exercises.
Live Virtual Training: Engage with expert trainers from anywhere.
On-Demand Modules: Learn at your own pace with pre-recorded content.
Ready to Elevate Your Validation Expertise?
Contact us today to learn more about CAGES℠ Training and how it can transform your approach to process validation.