ADVANCED CERTIFICATION COURSE IN PHARMACEUTICAL ANALYTICAL RESEARCH

Key Aspects of the Course: Method Development: Detailed instruction in analytical techniques including HPLC, GC, UV, FTIR, and Dissolution testing. Focus on method optimization for accurate and reliable analysis. ICH Guidelines on Impurities: In-depth exploration of ICH guidelines concerning impurities like organic, residual solvents, elemental, and genotoxic impurities. Special emphasis on the detection and management of nitrosamines. Quality Management Systems (QMS): Comprehensive overview of QMS elements such as OOS, Change Control, Deviation, and CAPA. Guidance on effective implementation of these systems to maintain quality. Equipment Qualification and Calibration: Training in the qualification and calibration of laboratory equipment. Emphasis on the importance of these processes for accurate results. Method Validation, Transfer, and Verification: Extensive training in method validation to ensure consistency and reliability of results. Best practices in method transfer and verification across laboratories. Training for Pharmaceutical Personnel: The importance of training for analytical research personnel. Methods to ensure compliance with regulatory standards. Audits and Inspections: Strategies for preparing and managing regulatory audits and inspections. Understanding the role of audits in industry compliance. Operation of Key Lab Instruments: Practical knowledge in operating important laboratory instruments. Cleaning Validation: Principles and practices in cleaning validation, including glassware cleaning. Importance of these practices in preventing contamination. Vendor Qualification: Criteria for selecting and evaluating vendors. The role of vendor quality in the pharmaceutical supply chain.