Courses
Pharmaceutical QA
This course provides an overview of the principles and practices of quality assurance in the pharmaceutical industry. Students will learn about the regulatory requirements, quality systems, and risk management strategies used to ensure the quality of pharmaceutical products.
Course Outcomes:-
1. Understand the regulatory framework: Familiarize with the regulatory requirements and guidelines for pharmaceutical quality assurance, including ICH, FDA, and EU guidelines.
2.Quality systems and management: Learn about the principles of quality systems, including quality by design (QbD), quality risk management (QRM), and corrective and preventive action (CAPA).
3. Risk management and assessment: Understand the principles of risk management and assessment, including failure mode and effects analysis (FMEA) and hazard analysis and critical control points (HACCP).
4. Good manufacturing practices (GMP): Familiarize with the principles of GMP, including personnel, premises, equipment, and documentation.
5. Auditing and inspection: Learn about the principles of auditing and inspection, including the preparation of audit reports and the implementation of corrective actions.
6.Quality control and testing: Understand the principles of quality control and testing, including the use of statistical process control (SPC) and the validation of analytical methods.
7. Supply chain management: Familiarize with the principles of supply chain management, including the selection and qualification of suppliers, and the management of inventory and logistics.
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