Advanced Certificate in Biopharma Quality Management Systems
-- ViewingNowThe Advanced Certificate in Biopharma Quality Management Systems course is a comprehensive program designed to provide learners with the essential skills required in the biopharma industry. This course emphasizes the importance of implementing and maintaining quality management systems that comply with regulatory standards.
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โข Quality Management System (QMS) Overview: Understanding the fundamental concepts, principles, and components of a QMS in the biopharma industry.
โข Regulatory Compliance in Biopharma: An in-depth analysis of regulations and guidelines governing biopharma QMS, including FDA, EMA, and ICH requirements.
โข Quality Risk Management (QRM): Implementing and managing QRM methodologies and tools to identify, assess, and mitigate risks in biopharma operations.
โข Quality Assurance and Control: Establishing and maintaining quality assurance and control systems to ensure product quality, safety, and efficacy.
โข Document Management and Control: Implementing and managing document management and control systems for GxP records and documents.
โข Change Management: Managing changes in the biopharma QMS, including change identification, evaluation, approval, implementation, and verification.
โข Supplier Quality Management (SQM): Managing suppliers and their contributions to the biopharma QMS, ensuring compliance with regulations and quality standards.
โข Continuous Improvement in Biopharma QMS: Implementing and managing continuous improvement programs, including process optimization, Six Sigma, and Lean.
โข Quality Metrics and Analytics: Developing and implementing quality metrics and analytics to monitor, analyze, and improve biopharma QMS performance.
โข Auditing and Inspection Preparedness: Conducting internal audits and preparing for external inspections to ensure QMS compliance and readiness.
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