PTI - international

Agenda: Day One

I. Define the Essential Job Functions of the QA Professional  *Updated*

• Compare QA vs. QC
• Review steps for Quality improvement and planning
• Discuss QA job functions and responsibilities as they relate to various job paths
• Embrace the concept of "a checks and balances" (assuring quality!) approach based on the intent of the regulations

Exercise: Create a Comparative Table with Regulations

II. Examine the Essential Regulatory Requirements Attributed to Quality Assurance *Updated*

• Compare and contrast domestic and international regulations
• Interpret guidelines to determine what is expected to meet requirements
• Review guidelines for quality systems and controls
  • GMPs for the 21st Century
    • Quality Systems Guidelines
    • Process Validation Guidelines (Policy Guide CG 7132C.08)
    • PAT (Process Analystical Technology) Guidance
  • Assess 21 CFR Part 11 (Electronic Records and E-Signatures)

III. Maximize Quality Performance throughout the Production Process

• Identify the benefits of design reviews in helping ensure regulatory compliance
• Ensure plant compliance with registration expectations and regulatory submissions
• Limit and manage change control

IV. Improve Technology/Method Transfer Processes

• Maintain quality during the method transfer
• Set specifications and analyze tolerance requirements

V. Maximize Quality Performance Related to Validation

• Define QA's responsibilities with regard to process and equipment validation
• Implement process controls and ongoing validation strategies
• Assess the importance of a maintenance and calibration program
• Perform computer and software validation

VI. Perform Effective Quality Audits

• Apply proven, practical auditing techniques
• Anticipate and respond to compliance challenges
• Dissect the QSIT approach
• Examine systems-based inspection for the drug industry

Exercise: Complete and Review Sample SOPs and Other Documentation