Workshop Overview
This workshop covers the fundamentals of Annual Product Quality Reviews (APQRs), focusing on regulatory compliance, process improvement, and preparing for GMP inspections. Participants will learn the core principles, the contents of an APQR, and how to assess APQR data for corrective actions and improvements.
Who Should Attend
This workshop is ideal for individuals involved in the preparation, review, or management of Annual Product Quality Reviews required for GMP compliance. It is particularly beneficial for quality assurance professionals, regulatory affairs specialists, manufacturing personnel, and team leads responsible for ensuring product quality, regulatory compliance, and continuous improvement in their organizations.
Workshop Outline
This workshop covers the following topics:
- Introduction to Annual Product Reviews (APQRs/PQRs)
- Key Benefits and Purpose of Effective APQRs
- Typical Contents of an APQR
- Records and Data Management for APQRs
- Statistical Analysis of APQR Data
- Approach for Preparing an APQR
- HPB/FDA Expectations for APQRs
- Bottom Line on the Importance of APQRs
- Hands-on application and group discussions
Learning Outcomes
Understand the Role of APQRs in Compliance
Gain a clear understanding of how APQRs ensure regulatory compliance and support quality management.
Master the Structure and Content of APQRs
Learn how to structure and organize APQR data effectively, ensuring it is comprehensive and aligned with regulatory expectations.
Develop Skills in Data Analysis for APQRs
Understand how to analyze and interpret statistical data from APQRs to identify trends, deviations, and areas for improvement.
Apply Practical Techniques for APQR Preparation
Participate in hands-on exercises to reinforce best practices in preparing and reviewing APQRs, with a focus on corrective actions and compliance.
All participants will receive a certificate of attendance upon completion.
