Masterclass Certificate in Pharma Quality Assurance Methods
-- ViewingNowThe Masterclass Certificate in Pharma Quality Assurance Methods is a comprehensive course that equips learners with critical skills in pharmaceutical quality assurance. This program emphasizes the importance of maintaining high-quality standards in drug manufacturing, ensuring compliance with regulations, and promoting patient safety.
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⢠Quality Assurance Fundamentals: An introduction to the key principles and concepts of Quality Assurance (QA) in the pharmaceutical industry. This unit will cover the importance of QA, regulatory requirements, and the role of a QA professional.
⢠Quality Risk Management: This unit will explore the methods and tools used to identify, assess, and control risks associated with pharmaceutical products and processes. It will also cover the implementation of Quality Risk Management systems.
⢠Regulatory Compliance for Pharma QA: An in-depth look at the regulations and guidelines governing pharmaceutical QA, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
⢠Quality Control in Pharmaceuticals: This unit will cover the methods and techniques used to ensure the quality of pharmaceutical products, including testing, validation, and documentation.
⢠Quality System Management: This unit will explore the development, implementation, and maintenance of Quality Systems, including Quality Manuals, Standard Operating Procedures (SOPs), and Quality Control Plans.
⢠Change Management in Pharma QA: This unit will cover the processes and procedures for managing changes to pharmaceutical products, processes, and systems, including Change Control, Deviation Management, and Corrective and Preventive Action (CAPA).
⢠Quality Audits and Inspections: An overview of the methods and techniques used to conduct internal and external audits and inspections of pharmaceutical products, processes, and systems.
⢠Continuous Improvement in Pharma QA: This unit will cover the methods and techniques for continuous improvement in pharmaceutical QA, including Lean Six Sigma, Statistical Process Control (SPC), and Root Cause Analysis (RCA).
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