Annual Product Reviews (APR/PQR) are a core GMP requirement and a frequent focus of FDA, EU, and Health Canada inspections. Inadequate reviews have been cited in FDA 483s and Warning Letters, and highlighted by EMA and Health Canada inspectors. Product reviews are critical for continuous improvement, aligning with ICH Q10 and FDA’s Quality Systems guidance. With FDA Quality Metrics initiatives, their importance is increasing. A well-prepared APR not only ensures compliance but also drives CAPAs and operational improvements.

This webinar will explore worldwide requirements, differences in geographic expectations, management’s role under the FDA Quality Metrics program, and practical systems for APR preparation. You will learn how to transform the APR from a burdensome compliance exercise into a valuable tool supporting continuous improvement and a modern Pharmaceutical Quality System.

Learning Benefits

• Understand requirements for APRs and PQRs
• Differentiate Annual Product Reviews from Annual Reports
• Use the APR as a Stage 3 process validation tool
• Apply continued process verification principles
• Know what should be included in APRs
• Learn effective preparation strategies
• Support continuous improvement through product reviews
• Understand management’s role in APRs
• Review regulations: US 21 CFR 211.180(e), EU GMP 1.5, Canada GUI-0001 C.02.011, ICH Q10
• Assess the impact of FDA’s Quality Metrics program

Who Should Attend

• Senior Management
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Regulatory Compliance
• QA Product Reviewers
• Manufacturing Operations
• Procurement Staff
• Engineering Staff
• Validation Teams
• Personnel involved in APR preparation