PTI - international

VII. Ensure Quality in the Laboratory

• Analyze inspection approaches by FDA
• Comply with regulatory requirements for personnel training and equipment validation
• Evaluate the importance of statistics to justify test results

VIII. Maintain Vendor and Supplier Management

• Evaluate and monitor suppliers and vendors
• Identify and qualify reliable sources for raw materials, packaging, manufacturing and testing
• Identify the main components of an effective supplier agreement
• Conduct vendor audits

Exercise: Analyze Case Studies

IX. Improve Documentation Practices

• Determine what must be documented
• Ensure documentation control and identify validation "red flags"
• Create SOPs, protocols, Master Validation Plans (MVPs) and other required validation documentation

Exercise: Complete and Review Sample SOPs and Other Documentation

X. Manage Non-Conformances, Deviations and Complaints

• Examine Corrective and Preventive Action (CAPA)
• Identify requirements for an effective change control program and the common errors associated with them
• Perform OOS investigations

Exercise: Examine Examples of Deviations and Investigations

XI. Conduct Batch Record Reviews

• Execute batch identification procedures
• Assess packaging requirements
• Determine criteria to release or reject APIs

XII. Examine Statistics, Control Charts and Evaluate Statistical Tools

• Examine QSR Section 820.250 Statistical Techniques Requirements
• Define reliability and variability
• Examine statistical tools
• Maintain standards and traceability

Exercise: Control Charts

XIII. Assess Current Regulatory Activity *Updated*

• Avoid common quality-related 483s and Warning Letters
• Evaluate current  483s trigger points
• Prepare for FDA audit and execute the steps to be taken during the audit

Exercise: Examine Case Scenarios from FDA Inspector's Point of View