Annual Product Quality Reviews – Preparation, Reports, Impact of Latest Quality Metrics Guidance

• 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

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.