Pharmaceutical Quality management system and compliance in the Pharmaceutical Industry
Course Overview
Develop a comprehensive understanding of Pharmaceutical Quality Management Systems (PQMS) and learn how to establish, implement, and continuously improve quality systems in compliance with EU GMP, FDA cGMP, WHO GMP, PIC/S, and ICH guidelines. This course covers Quality Risk Management, Change Control, Deviation Management, CAPA, Product Quality Review, Vendor Qualification, Complaint Handling, Recall Management, Self-Inspection, and Management Review.
What You'll Learn?
- Understand the principles and regulatory requirements of a Pharmaceutical Quality Management System.
- Interpret the requirements of EU GMP, WHO GMP, PIC/S, and ICH Q10.
- Understand the quality culture and lifecycle approach within pharmaceutical manufacturing.
- Implement Quality Risk Management (ICH Q9) to support decision-making.
- Establish and manage effective Change Control processes.
- Investigate deviations using structured Root Cause Analysis tools.
- Develop effective CAPA plans to prevent recurrence.
- Manage customer complaints and product recalls.
- Perform Product Quality Reviews (PQR/APQR) and identify improvement opportunities.
- Plan and conduct self-inspections and internal GMP audits.
- Qualify and monitor suppliers and service providers using risk-based approaches.
- Conduct effective Management Review meetings and monitor Quality Management System performance.
- Prepare for regulatory inspections and maintain inspection readiness.
- Quality Assurance (QA) Professionals
- Quality Control (QC) Professionals
- Qualified Persons (QPs)
- Production Pharmacists
- Manufacturing Managers
- Quality Managers
- GMP Compliance Officers
- Validation staff
- Regulatory Affairs Specialists
- Engineering Managers
- Warehouse and Supply Chain Managers
- Procurement and Vendor Qualification Personnel
- Internal Auditors
- CAPA Coordinators
- Pharmaceutical fresh graduates
- Supervisors and Department Managers involved in pharmaceutical quality systems
- knowledge of pharmaceutical manufacturing is recommended.
- Active participation in discussions and case studies is encouraged.
- Complete the final assessment to receive the certificate.
- Student Handbook with Course Presentation Slides including :Workshop Exercises ,Case Studies ,Template protocols ,Audit Checklist
- ,Reference Guidelines ,Assessment Quiz ,Certificate of Completion
Course Content
- Day 1: Introduction to Pharmaceutical Quality Management Systems
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Day 2: Change Management and PQR
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Lesson 1: Change Management
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Lesson 2: Product Quality Review (PQR/APQR)
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Day 3: QRM and Vendor Qualification
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Lesson 1: Quality Risk Management
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Lesson 2: Risk based Vendor Qualification
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Day 4: Deviation Handling, Investigation & CAPA
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Lesson 1: Deviation Handling, Investigation & CAPA
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Lesson 2: Complaint Handling & Product Recall
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