Executive Development Programme in Pharmaceutical Inspection Techniques
-- ViewingNowThe Executive Development Programme in Pharmaceutical Inspection Techniques is a certificate course designed to provide learners with the essential skills required for successful pharmaceutical inspections. This program emphasizes the importance of rigorous inspection methodologies to ensure compliance with regulatory standards and guarantee the safety and efficacy of pharmaceutical products.
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⢠Pharmaceutical Inspection Fundamentals: An introduction to the essential concepts, principles, and regulations of pharmaceutical inspection techniques. This unit will cover primary keywords such as GxP (Good Practice) guidelines, Quality Management Systems (QMS), and regulatory bodies like the FDA and EMA.
⢠Good Manufacturing Practices (GMP): This unit will delve into GMP principles, focusing on production, quality control, and documentation. It will discuss critical topics such as premises, equipment, personnel, and sanitation.
⢠Good Laboratory Practices (GLP): This unit will cover the essentials of GLP, including its history, principles, and implementation in laboratory settings. It will discuss the importance of data integrity, documentation, and quality assurance in laboratory testing.
⢠Good Clinical Practices (GCP): This unit will discuss GCP principles and their impact on clinical trials, data management, and patient safety. It will cover topics such as informed consent, study design, and data analysis.
⢠Pharmaceutical Quality Systems: This unit will focus on implementing and maintaining quality systems in the pharmaceutical industry, covering essential topics such as Quality Risk Management (QRM), Corrective and Preventive Action (CAPA), and Change Management.
⢠Regulatory Compliance and Auditing Techniques: This unit will discuss the critical aspects of regulatory compliance, including internal and external audits. It will cover topics such as audit preparation, execution, and follow-up, as well as the handling of regulatory inspections.
⢠Pharmaceutical Validation Techniques: This unit will cover the essentials of validation in the pharmaceutical industry, including process validation, cleaning validation, and computer system validation. It will discuss the importance of validation master plans and documentation.
⢠Pharmaceutical Inspection Skills and Techniques:
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