Product Quality Review and Annual Product Review are the favorite documents for the inspectors and QPs. This pandemic is impacted on auditing also. Many regulatory agencies are planning audits based on risk-based approach. The Annual Product Quality Review (APQR) and Quality Metrics are two major tools which will help agencies to perform risk assessment and plan the audits. Furthermore, APQR is nothing but complete ‘Natal Chart’ of the product and quality system.
APQR should have complete and correct information. Any missing or wrong information may lead to serious non-conformance. In this training session, we will discuss about how to prepare APQR, how to do statistical evaluation, how to perform supply chain traceability and many more. Furthermore, we will focus on some Quality Metrics by FDA and how they can be implemented. During this seminar, we will be able to prepare, review and approve PQR in a more efficient way.
Seminar Agenda:
– Regulatory Requirements for APQR
– Overview & comparison of the regulations and agency (FDA, EU, Canada, WHO) expectations
– Standard Operating Procedures
– Responsibilities, content and scope
– The Product Review as a tool in Stage 3 of Process Validation – – Continued process verification
– ICH Q10; Pharmaceutical Quality System
– The impact of the New FDA Quality Metrics program
– How to apply Risk Management tools
– Performing statistical evaluation in PQR
– Common Practical problems during PQR
– Organizing, Presentation, concluding and approval of the report
ISEM1408
