PTI - international

Agenda: Day One

I. Examine the History of the Quality Systems Approach

•  Trace the Quality System Regulation for the medical device industry
• Outline key FDA issues addressed in the new quality systems guidance for pharmaceuticals
• Clarify compliance issues related to 21 CFR parts 210 and 211
• Compare ISO 9000 to ICH Q8, Q9, Q10 initiatives and GMP regulations on quality systems and address harmonization
• Determine appropriate considerations for a compliant quality system

Exercise: Develop a Checklist for Regulatory Submissions Compliance in Accordance with Quality Systems Guidelines

 II. Differentiate Between the Quality System and the Five Manufacturing Systems

• Evaluate the components of a quality system:
  • Production System
  • Facilities & Equipment System
  • Laboratory Controls System
  • Materials System
  • Packaging & Labeling System
• Discuss the interdependence of the six systems in achieving regulatory compliance
• Construct a framework for ensuring "quality by design" in product development
• Assess the importance of the Systems-Based Inspection

Exercise: Create a Matrix Connecting Quality Activities and the Manufacturing Systems that are Impacted by each Activity

III. Explore Management Responsibilities to Ensure a Robust Quality System

• Implement quality risk-management principles at each stage of the product life-cycle
• Assess the effectiveness of current quality systems policies and procedures
• Outline job responsibilities at each level to support the quality systems process
• Integrate active employee participation in system design and implementation
• Critique an effective implementation plan
• Understand the benefits of a quality manual
• Design SOPs for quality systems compliance

Exercise: List SOPs that Support a Quality Systems Approach to GMPs

IV. Leverage Resources to Create a Culture of "Quality"

• Critique quality systems training methods for employees
• Support a culture of quality by "living the processes" and encourage internal communication on quality issues and systems support
• Monitor facilities and equipment for GMP compliance
• Ensure adequate control of outsorced operations in support of the quality process

Exercise: Training Employees to Support "Quality"

V. Monitor Manufacturing Activities

• Review GMP requirements
• Incorporate the packaging and labeling system into documented procedures
• Test quality control activities to ensure reliable input materials
• Implement process improvements throughout the product life cycle by conducting thorough batch record reviews and change control activities

Exercise: Case Scenario