Program Overview
This program provides a comprehensive understanding of pharmaceutical QMS principles, compliance with regulatory standards (cGMP, FDA, WHO, and ISO 9001), and best practices in quality control (QC). Participants will gain hands-on experience in critical areas such as Quality by Design (QbD), risk management, documentation integrity, laboratory controls, and deviation investigations. Through workshops, case studies, and practical exercises, this program focuses on identifying, analyzing, and resolving quality issues while fostering a culture of continuous improvement in QC operations.
Features
- Understand QMS fundamentals, regulatory compliance, and their role in QC operations.
- Apply Quality by Design (QbD) principles and risk management frameworks to QC processes.
- Develop skills in deviation investigation, RCA, CAPA implementation, and data integrity.
- Leverage quality metrics, Lean Six Sigma, and QC tools for process improvement.
Target audiences
- Pharmaceutical Quality Control (QC) professionals
- Quality Assurance (QA) teams
- Regulatory Affairs specialists
- Production Managers, and Compliance Officers
Instructor
