Duration: 6 Hours | Course Director: HITENDRAKUMAR SHAH

  • Product ID: ISEM1408

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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.

  • 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

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments

Course Director:

HitendraKumar Shah is a renowned Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities. His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is a popular figure on social media for his effective and easily understandable training bites.