Sign Up for Training Announcements!
Your Participant Benefits
- Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements
- Conduct internal audits to monitor quality and apply corrective actions when appropriate
- Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed
- Organize and manage evaluation data to improve product quality and address customer complaints
Organization Benefits
- Operate a GMP compliant manufacturing operation that supports changes to facilities, equipment, and processes to support product improvement
- Save money and ensure product quality by encouraging “quality by design”
- Improve product safety and integrity through increased quality monitoring at all stages of the manufacturing process
- Prepare for the FDA’s systems based inspection
After This Training Course, You Will Be Able To:
- Track and organize data efficiently to improve the evaluation process
- Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
- Integrate risk assessment activities into the product design process to meet expectations of “quality by design”
- Identify crucial training issues to address job-specific compliance responsibilities
- Demonstrate a proactive approach to quality and improve operational efficiency
- Anticipate and meet FDA expectations for a compliant quality system
- Incorporate risk-management strategy to quality systems application
- Build a quality-focused culture and facilitate management support for quality systems processes
