ADVANCED CERTIFICATION COURSE IN PHARMACEUTICAL QUALITY ASSURANCE

Key Components of the Course: Good Manufacturing Practices (GMP): Deep dive into GMP principles and their application in the pharmaceutical industry. Understanding the role of GMP in ensuring product quality and safety. Preparation of Key Documents: Training in the preparation of crucial documents like the Site Master File, Master Validation Plan, and Quality Manual. Learning the importance of these documents in maintaining quality standards. ICH Guidelines on Impurities: Comprehensive understanding of ICH guidelines regarding various impurities, including organic, residual solvents, elemental, and genotoxic impurities. Special focus on the identification and control of nitrosamines. Quality Management Systems (QMS): Detailed exploration of QMS elements such as Out of Specification (OOS) results, Change Control, Deviation Management, and Corrective and Preventive Actions (CAPA). Emphasis on the importance of these systems in maintaining consistent quality. Equipment Qualification and Calibration: Instruction on the processes for qualifying and calibrating equipment in a pharmaceutical setting. Understanding the significance of these practices in ensuring accurate and reliable results. Method Validation, Transfer, and Verification: In-depth knowledge of method validation processes and their importance in ensuring test result reliability and consistency. Best practices for method transfer and verification to maintain quality standards. Training for Pharmaceutical Personnel: Focus on the necessity and methods of training for personnel involved in quality assurance. Ensuring that staff is well-equipped to uphold regulatory standards. Audits and Inspections: Preparing for and managing regulatory audits and inspections effectively. Understanding the critical role of audits in maintaining industry compliance. Operation of Key Lab Instruments: Hands-on knowledge about the operation of crucial laboratory instruments in quality assurance. Cleaning Validation.....