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  • 60Steps
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It focuses on imparting a deep understanding of the quality control aspects in pharmaceutical production, in line with the latest industry standards Key Course Highlights: ICH Guidelines on Impurities: Comprehensive coverage of ICH guidelines related to various impurities such as organic, residual solvents, elemental, and genotoxic impurities. Special focus on nitrosamine, its identification, and control measures. Quality Management Systems (QMS): Detailed exploration of QMS elements like Out of Specification (OOS) results, Change Control, Deviation Management, and Corrective and Preventive Actions (CAPA). Emphasis on the implementation and management of these systems to uphold quality standards. Equipment Qualification and Calibration: Understanding the importance and processes for equipment qualification in a QC lab. Calibration procedures to ensure accurate and reliable data from laboratory instruments. Method Validation, Transfer, and Verification: In-depth knowledge on method validation processes ensuring the reliability and consistency of test results. Best practices in method transfer and verification between laboratories or within the same organization. Training for Pharmaceutical Personnel: Emphasis on the necessity of proper training for personnel involved in quality control. Training methodologies to ensure compliance with regulatory standards. Audits and Inspections: Preparing for and effectively managing regulatory audits and inspections. Understanding the criticality of audits in maintaining industry compliance. Operation of Key Lab Instruments: Hands-on knowledge of operating essential laboratory instruments used in pharmaceutical quality control. Cleaning Validation: Principles and practices of cleaning validation to ensure no cross-contamination. Special focus on glassware cleaning validation in the QC lab. Vendor Qualification: Criteria for selecting and assessing vendors. Importance of vendor quality in the pharmaceutical supply chain.

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From ₹3,900.00


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