Global Certificate in Pharmaceutical Quality Assurance Standards
-- ViewingNowThe Global Certificate in Pharmaceutical Quality Assurance Standards course is a comprehensive program that equips learners with the essential skills needed for success in the pharmaceutical industry. This course focuses on the importance of quality assurance standards, their implementation, and compliance in pharmaceutical manufacturing and distribution.
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โข Pharmaceutical Quality Assurance Standards Overview: Introduction to quality assurance in the pharmaceutical industry, regulatory bodies, and international standards such as GMP (Good Manufacturing Practices) and ISO 9001. โข Quality Risk Management: Understanding and implementing quality risk management principles in the pharmaceutical industry, including risk identification, assessment, and control strategies. โข Quality Control and Assurance Laboratories: Designing, equipping, and operating quality control and assurance laboratories, as well as managing laboratory data. โข Documentation and Record Keeping: Best practices for creating and maintaining documentation and records, including SOPs (Standard Operating Procedures), deviations, and change control. โข Validation and Qualification: Understanding and implementing validation and qualification processes, including computerized systems, equipment, and facilities. โข Change Management: Managing changes in the pharmaceutical industry, including change control, impact assessment, and approval processes. โข Auditing and Inspections: Conducting internal audits, preparing for regulatory inspections, and managing inspection findings. โข Pharmaceutical Supply Chain Management: Ensuring quality throughout the pharmaceutical supply chain, including supplier management, transportation, and storage.
โข Continuous Improvement: Implementing continuous improvement principles, such as Six Sigma and Lean, in the pharmaceutical industry. โข Complaint Handling and Recall Management: Managing complaints, investigations, and recalls, including root cause analysis and corrective action plans.
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